Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001457235
Ethics application status
Approved
Date submitted
20/08/2018
Date registered
29/08/2018
Date last updated
27/02/2020
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Scientific title
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Secondary ID [1] 295850 0
NCT03611478
Secondary ID [2] 295851 0
NH-03884
Universal Trial Number (UTN)
NH-03884
Trial acronym
PS_FOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Fatigue 309309 0
Cognitive Function 309310 0
Mood 309311 0
Condition category
Condition code
Mental Health 308178 308178 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Probiotic capsule - Contains a probiotic formulation. One capsule to be taken by mouth once daily for 28 days.

Enough treatment will be dispensed to participants to cover the entire 28 days of the study, along with an additional 12 days’ supply in case the end date is delayed. Participants will be asked to complete a Treatment Log and return all unused capsules to assess compliance.

Clinic visits will take place at screening (Visit 0), baseline (Visit 1) and 28 days post intervention (Visit 2). At Visit 0 voluntary written informed consent will be provided by participants, eligibility will be confirmed, and participants will practice completing the mood questionnaires and cognitive assessments. Visit 1 will be completed within 14 days of screening. At this visit, participants will complete the mood and cognitive assessments, and will be randomized and provided with their allocated study treatment (probiotic formulation or matched placebo). The final session will occur 28 days (not exceeding 40 days) after they start their supplementation, and participants will follow the same procedure as Visit 1 (excluding randomization and treatment dispensing).
Intervention code [1] 312190 0
Treatment: Other
Comparator / control treatment
Placebo Comparator: Placebo - Matching placebo capsule to be taken once daily by mouth for 28 days. Contains microcrystalline cellulose, silicon dioxide, and magnesium stearate.

Placebo capsule identical in taste and appearance to probiotic capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 307143 0
Mental fatigue score (VAS-mental fatigue) - Difference in mental fatigue score as the participant moves through six cycles of a cognitive demand battery (CDB). The cognitive demand battery consists of three tasks (RVIP, serial threes and serial sevens, described below), and is designed to increase cognitive load. Six cycles of the battery are completed in succession at each testing visit. The mental fatigue scale (VAS-mental fatigue) is completed after each cycle of the CDB (6 times over the course of one hour, per visit). Participants rate their level of mental fatigue on a 100-mm scale from "not at all" to "extremely". The primary outcome is difference in mental fatigue score (VAS-mental fatigue) as the participant moves through the six cycles of the CDB, (after cognitive load) absolute change from baseline (Visit 1) to 28 days (Visit 2) between the active vs placebo group.
Timepoint [1] 307143 0
28 days post-first dose
Secondary outcome [1] 350840 0
RVIP number correct - Percentage of target strings correctly detected on the rapid visual information processing (RVIP) task throughout each of the six cycles of the CDB. In this task, which lasts for 5 minutes, a series of numbers rapidly appear on the screen one at a time. Participants are instructed to press the space bar whenever they detect a sequence of either 3 consecutive odd or 3 consecutive even numbers.
Timepoint [1] 350840 0
28 days post-first dose
Secondary outcome [2] 350841 0
RVIP reaction time - Average reaction time for correct detections (RVIP) throughout each of the six cycles of the CDB.
Timepoint [2] 350841 0
28 days post-first dose
Secondary outcome [3] 350842 0
RVIP false alarms - The number of false alarms (RVIP) throughout each of the six cycles of the CDB
Timepoint [3] 350842 0
28 days post-first dose
Secondary outcome [4] 350843 0
Serial threes subtraction total - Total number of subtractions on the serial threes subtraction task, regardless of whether correct or incorrect, throughout each of the six cycles of the CDB. In this two minute task, participants are given a starting number and instructed to subtract three from this number. They must then type in the number they are left with and press enter. After this no numbers are visible but the participant must continue to subtract three and enter their responses.
Timepoint [4] 350843 0
28 days post-first dose
Secondary outcome [5] 350844 0
Serial threes errors - Total number of incorrect subtractions (serial threes subtraction task) throughout each of the six cycles of the CDB
Timepoint [5] 350844 0
28 days post-first dose
Secondary outcome [6] 350845 0
Serial sevens total - Total number of subtractions (serial sevens subtraction task) throughout each of the six cycles of the CDB. This task is the same as the serial threes task, except that participants must subtract seven instead of three.
Timepoint [6] 350845 0
28 days post-first dose
Secondary outcome [7] 350846 0
Serial sevens errors - Total number of errors (serial sevens subtraction task) throughout each of the six cycles of the CDB
Timepoint [7] 350846 0
28 days post-first dose
Secondary outcome [8] 350847 0
Immediate word recall - correct - The number of correctly identified words in the immediate word recall task. Participants see a list of 15 words that they are instructed to remember. After seeing the last word, the participant has 60 seconds to write down as many of the words as they can remember.
Timepoint [8] 350847 0
28 days post-first dose
Secondary outcome [9] 350848 0
Immediate word recall - errors - The number of errors in the immediate word recall task (words not included in the original list)
Timepoint [9] 350848 0
28 days post-first dose
Secondary outcome [10] 350849 0
Immediate word recall - intrusions - The number of intrusions in the immediate word recall task (words similar to those included in the original list but not identical).
Timepoint [10] 350849 0
28 days post-first dose
Secondary outcome [11] 350850 0
Delayed word recall - Correct - The number of correctly identified words in the delayed word recall task. After completing the CDB (approximately one hour after presentation of the 15 words), the participant has 60 seconds to write down as many of the words as they can remember from the original list.
Timepoint [11] 350850 0
28 days post-first dose
Secondary outcome [12] 350851 0
Delayed word recall - errors - The number of errors in the delayed word recall task (words not included in the original list)
Timepoint [12] 350851 0
28 days post-first dose
Secondary outcome [13] 350852 0
Delayed word recall - intrusions - The number of intrusions in the delayed word recall task (words similar to those included in the original list but not identical).
Timepoint [13] 350852 0
28 days post-first dose
Secondary outcome [14] 350853 0
Delayed word recognition - reaction time - Mean reaction time to word recognition in delayed word recognition task following cognitive load. After participants have viewed the word list and completed the immediate word recall task, they complete the CDB which lasts for one hour. On completion of the CDB, participants complete a word recognition task. In this task, the original 15 target words plus an additional 15 distractor words are presented one at a time, in a randomized order. Participants are instructed to indicate whether or not they recognize the word from the original list by pressing the 'Yes' or 'No' button as appropriate as quickly as possible, mean reaction times are measured in msec.
Timepoint [14] 350853 0
28 days post-first dose
Secondary outcome [15] 350854 0
Word recognition - original words accuracy - Accuracy of responses (%) to original target words in delayed word recognition task following cognitive load (CDB).
Timepoint [15] 350854 0
28 days post-first dose
Secondary outcome [16] 350855 0
Word recognition - distractor words accuracy - Accuracy of responses (%) to novel distractor words in delayed word recognition following cognitive load (CDB).
Timepoint [16] 350855 0
28 days post-first dose
Secondary outcome [17] 350856 0
Self-reported alertness score - Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The alertness score is calculated by averaging scores on lines anchored by alert-drowsy, attentive-dreamy, lethargic-energetic, muzzy-clearheaded, well-coordinated-clumsy, mentally slow-quick witted, strong-feeble, interested-bored, incompetent-proficient. This is completed before and after the CDB.
Timepoint [17] 350856 0
28 days post-first dose
Secondary outcome [18] 350857 0
Self-reported contentment score - Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The contentment score is calculated by averaging scores on lines anchored by contented-discontented, troubled-tranquil, happy-sad, antagonistic-friendly, withdrawn-sociable. This is completed before and after the CDB.
Timepoint [18] 350857 0
28 days post-first dose
Secondary outcome [19] 350858 0
Self-reported calmness score - Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The calmness score is calculated by averaging scores on lines anchored by calm-excited, tense-relaxed. This is completed before and after the CDB.
Timepoint [19] 350858 0
28 days post-first dose
Secondary outcome [20] 350859 0
Difference in self-reported stress score (VAS-stress) before and after a cognitive load - The Stress Visual Analogue Scale (VAS-Stress) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "stressed" they feel at that point in time. This is completed twice in each session, once prior to the CDB, and once after the battery is complete. The difference between pre- and post-CDB score is calculated, and the difference is compared between baseline and 28 days.
Timepoint [20] 350859 0
28 days post-first dose
Secondary outcome [21] 350860 0
Self-reported stress score (VAS-stress) - pre-CDB only - The Stress Visual Analogue Scale (VAS-Stress) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "stressed" they feel at that point in time. The pre-CDB score is compared between baseline and 28 days to provide an assessment of stress without cognitive load.
Timepoint [21] 350860 0
28 days post-first dose
Secondary outcome [22] 350861 0
Difference in self-reported physical fatigue score (VAS-fatigue) before and after a cognitive load - The Physical Fatigue Visual Analogue Scale (VAS-fatigue) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "physically fatigued" they feel at that point in time. This is completed twice in each session, once prior to the CDB, and once after the battery is complete. The difference between pre- and post-CDB score is calculated, and the difference is compared between baseline and 28 days.
Timepoint [22] 350861 0
28 days post-first dose
Secondary outcome [23] 350862 0
Self-reported physical fatigue score (VAS-fatigue) - pre-CDB only - The Physical Fatigue Visual Analogue Scale (VAS-Fatigue) consists of a 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "physically fatigued" they feel at that point in time. The pre-CDB score is compared between baseline and 28 days to provide an assessment of physical fatigue without cognitive load.
Timepoint [23] 350862 0
28 days post-first dose
Secondary outcome [24] 350863 0
Self-reported state anxiety (STAI) before and after a cognitive load - The 'State' subscale of the STAI contains 20 items, and requires participants to rate how much they feel like each item at the time of response. The scale is scored on a 4-point scale ranging from 'not at all' to 'very much so'. Scores range from 20 to 80, with higher scores indicating higher levels of anxiety. Participants will be required to complete the state version of the STAI twice per session, once before the commencement of the CDB, and once at completion.
Timepoint [24] 350863 0
28 days post-first dose
Secondary outcome [25] 350864 0
Mental fatigue score on the Chalder Fatigue Scale - The 14-item Chalder Fatigue Scale (CFS) measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Timepoint [25] 350864 0
28 days post-first dose
Secondary outcome [26] 350865 0
Physical fatigue score on the Chalder Fatigue Scale - The 14-item CFS measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Timepoint [26] 350865 0
28 days post-first dose
Secondary outcome [27] 350866 0
Total fatigue score on the Chalder Fatigue Scale - The 14-item CFS measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Timepoint [27] 350866 0
28 days post-first dose
Secondary outcome [28] 350867 0
Self-reported sleep quality - total score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [28] 350867 0
28 days post-first dose
Secondary outcome [29] 350868 0
Self-reported duration of sleep score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [29] 350868 0
28 days post-first dose
Secondary outcome [30] 350869 0
Self-reported sleep disturbance score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [30] 350869 0
28 days post-first dose
Secondary outcome [31] 350870 0
Self-reported sleep latency score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [31] 350870 0
28 days post-first dose
Secondary outcome [32] 350871 0
Self-reported daytime dysfunction score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [32] 350871 0
28 days post-first dose
Secondary outcome [33] 350872 0
Self-reported habitual sleep efficiency score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [33] 350872 0
28 days post-first dose
Secondary outcome [34] 350873 0
Subjective sleep quality score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [34] 350873 0
28 days post-first dose
Secondary outcome [35] 350874 0
Self-reported use of sleep medications score - The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Timepoint [35] 350874 0
28 days post-first dose
Secondary outcome [36] 350875 0
Self-reported vitality score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [36] 350875 0
28 days post-first dose
Secondary outcome [37] 350876 0
Self-reported physical functioning score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [37] 350876 0
28 days post-first dose
Secondary outcome [38] 350877 0
Self-reported bodily pain score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [38] 350877 0
28 days post-first dose
Secondary outcome [39] 350878 0
Self-reported general health perceptions score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [39] 350878 0
28 days post-first dose
Secondary outcome [40] 350879 0
Self-reported physical role functioning score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [40] 350879 0
28 days post-first dose
Secondary outcome [41] 350880 0
Self-reported emotional role functioning score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [41] 350880 0
28 days post-first dose
Secondary outcome [42] 350881 0
Self-reported social role functioning score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [42] 350881 0
28 days post-first dose
Secondary outcome [43] 350882 0
Self-reported mental health score (SF-36) - The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Timepoint [43] 350882 0
28 days post-first dose
Secondary outcome [44] 350883 0
Self-reported depression score (DASS-21) - The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Timepoint [44] 350883 0
28 days post-first dose
Secondary outcome [45] 350884 0
Self-reported anxiety score (DASS-21) - The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Timepoint [45] 350884 0
28 days post-first dose
Secondary outcome [46] 350885 0
Self-reported stress score (DASS-21) - The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Timepoint [46] 350885 0
28 days post-first dose
Secondary outcome [47] 350886 0
Self-reported confrontive coping score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [47] 350886 0
28 days post-first dose
Secondary outcome [48] 350887 0
Self-reported distancing score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [48] 350887 0
28 days post-first dose
Secondary outcome [49] 350888 0
Self-reported self-controlling score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [49] 350888 0
28 days post-first dose
Secondary outcome [50] 350889 0
Self-reported seeking social support score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [50] 350889 0
28 days post-first dose
Secondary outcome [51] 350890 0
Self-reported accepting responsibility score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [51] 350890 0
28 days post-first dose
Secondary outcome [52] 350891 0
Self-reported escape-avoidance score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [52] 350891 0
28 days post-first dose
Secondary outcome [53] 350892 0
Self-reported planful problem-solving score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [53] 350892 0
28 days post-first dose
Secondary outcome [54] 350893 0
Self-reported positive re-appraisal score (WAYS) - The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Timepoint [54] 350893 0
28 days post-first dose
Secondary outcome [55] 350894 0
Positive effects of on-trial experiences - At the completion of the trial, participants will be asked an open-ended question about any positive effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Timepoint [55] 350894 0
28 days post-first dose
Secondary outcome [56] 350895 0
Negative effects of on-trial experiences - At the completion of the trial, participants will be asked an open-ended question about any negative effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Timepoint [56] 350895 0
28 days post-first dose
Secondary outcome [57] 350896 0
Unusual effects of on-trial experiences - At the completion of the trial, participants will be asked an open-ended question about any unusual effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Timepoint [57] 350896 0
28 days post-first dose

Eligibility
Key inclusion criteria
1. Male or female, aged 18-50 years, inclusive.

2. Willing and able to provide written informed consent.

3. Ability of the participant (in the Principal Investigator's opinion) to comprehend the
full nature and purpose of the study including possible risks and side effects.

4. Agreement to comply with the protocol and study restrictions.

5. Available for all study visits.

6. Females of child-bearing potential required to provide a negative urine pregnancy test
and be using effective contraception (e.g. surgically sterilized (tubal ligation or
hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an IUD
(intrauterine device), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive (the pill) for at least 2 cycles before
the Screening-visit (Visit 0)).

7. Fluent in written and spoken English.

8. In good general health as judged by the Investigator/Clinical advisor based on medical
history.

9. Must have normal, or corrected to normal vision.

10. Body mass index between 18.5 and 29.9kg/m2 (inclusive).

11. Participant is willing to maintain habitual diet (including caffeine and alcohol) and
physical activity patterns throughout the study period.

12. Participant is willing and able to comfortably abstain from caffeine for 10 hours
prior to and throughout the test visits, (2-3 hours).

13. Participant is willing to abstain from alcohol for 12 hours and vigorous physical
activity for 12 hours prior to all study visits.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of dementia, stroke and other neurological conditions.

2. Traumatic loss of consciousness in the last 12 months.

3. History of epilepsy or Parkinson's disease.

4. Formal diagnosis of anxiety, depression or any psychiatric disorder that the Principal
Investigator believes would interfere with the objectives of the study and requiring
treatment (prescription of antidepressant, antipsychotic or other long term medication
and/or referral for long term psychotherapy) in the last 2 years. Brief interventions
for normal life events such as exam anxiety or bereavement are not an exclusion.

5. Have a significant acute or chronic coexisting illness (cardiovascular,
gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)),
immunological, metabolic (including diabetes or cardiovascular disease), endocrine or
bleeding disorders, neurodevelopmental or any condition which contraindicates, in the
Principal Investigator's judgement, entry to the study.

6. Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood
pressure >100 mm Hg).

7. Currently taking (from day of screening onwards) or have previously taken (last 4
weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics,
anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids,
opioid pain relievers).

8. Currently taking (from day of screening onwards) medication that the Principal
Investigator believes would interfere with the objectives of the study, pose a safety
risk or confound the interpretation of the study results such as:

- high dose anticoagulant medication such as warfarin, heparin, clopidogrel,
dabigatran, ticagrelor

- non-steroidal anti-inflammatory drugs (NSAIDS; excluded only for daily use)

- over-the-counter sleep medication (not categorized as sedatives, hypnotics or
anti-depressants)

- anti-cholinergic drugs or acetylcholinesterase inhibitors: bethanechol
(Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl),
neostigmine (Prostigmin)

- anti-histamines that cause drowsiness (eg. Ranitidine)

- pseudoephedrine and phenylephrine

9. Currently taking (from day of screening onwards) dietary supplements that the
Principal Investigator believes would interfere with the objectives of the study, pose
a safety risk or confound the interpretation of the study results such as: melatonin,
vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St. John's Wort
or other cognitive enhancing dietary or herbal supplements over the study period.

10. Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during
the intervention period.

11. Daily consumption of concentrated sources of probiotics and/or prebiotics within 2
weeks of screening and throughout the intervention period other than the provided
study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders or
yoghurts/yoghurt drinks containing probiotics).

12. Pregnant or lactating female, or pregnancy planned during intervention period.

13. Have self-reported dyslexia.

14. Current misuse of alcohol, drugs, or prescription medication.

15. Current smoker.

16. Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to
screening and during the intervention period.

17. Excessive alcohol consumption (drinking on 5 or more days a week) for 3 weeks prior to
screening and during the intervention period.

18. Contraindication to any substance in the investigational product.

19. Participation in another study with any investigational product within 30 days of
screening and during the intervention period.

20. Investigator believes that the participant may be uncooperative and/or noncompliant
and should therefore not participate in the study.

21. Participant under administrative or legal supervision.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
PRIMARY ANALYSIS
Primary analysis of outcomes will examine post-treatment scores using Analysis of Covariance (ANCOVA) for the between groups effect of treatment group, with baseline scores as a covariate. Primary analysis will be conducted on the Per-Protocol population, with all planned statistical tests performed two tailed at the 5% significance level.

SECONDARY ANALYSIS
Secondary analysis of outcomes will be conducted on the modified Intent-To-Treat population. This analysis will follow the same method, using post-treatment scores for the between groups effect of treatment, with baseline scores as a covariate using Analysis of Covariance (ANCOVA) and statistical tests performed two tailed at the 5% significance level.
Demographic data will be presented with summary statistics (number of participants, mean, standard deviation, median and range). The number and percentage of participants will be presented for categorical variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2018
Actual
6/09/2018
Date of last participant enrolment
Anticipated
28/02/2019
Actual
25/05/2019
Date of last data collection
Anticipated
29/03/2019
Actual
25/06/2019
Sample size
Target
128
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300451 0
Commercial sector/Industry
Name [1] 300451 0
DuPont Nutrition and Health
Country [1] 300451 0
Finland
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 299914 0
Commercial sector/Industry
Name [1] 299914 0
Danisco Australia Pty Ltd
Address [1] 299914 0
97 Waterloo Road
Macquarie Park, NSW 2113
Australia
Country [1] 299914 0
Australia
Other collaborator category [1] 280304 0
Commercial sector/Industry
Name [1] 280304 0
DuPont Nutrition and Health
Address [1] 280304 0
Global Health and Nutrition Science
Sokeritehtaantie 20
02460 Kantvik
Finland
Country [1] 280304 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301253 0
Bellberry Human Research Ethics Committee A [EC00372]
Ethics committee address [1] 301253 0
129 Glen Osmond Road
Eastwood
South Australia
5063
Ethics committee country [1] 301253 0
Date submitted for ethics approval [1] 301253 0
01/06/2018
Approval date [1] 301253 0
23/07/2018
Ethics approval number [1] 301253 0
2018-02-145
Ethics committee name [2] 301254 0
Swinburne University Human Research Ethics Committee [EC00240]
Ethics committee address [2] 301254 0
John St
Hawthorn
Victoria
3122
Ethics committee country [2] 301254 0
Australia
Date submitted for ethics approval [2] 301254 0
24/07/2018
Approval date [2] 301254 0
07/08/2018
Ethics approval number [2] 301254 0
SHR Project 2018/285

Summary
Brief summary
The aim of this study is to demonstrate the effects of 28-days supplementation with a novel
probiotic formulation on mental fatigue following a cognitive load in healthy adults. Half of
the participants will receive the probiotic formulation while the other half will receive
placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86374 0
Prof Andrew B Scholey, PhD
Address 86374 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 86374 0
Australia
Phone 86374 0
+61 3 9214 8932
Fax 86374 0
Email 86374 0
[email protected]
Contact person for public queries
Name 86375 0
Dr Naomi Perry
Address 86375 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 86375 0
Australia
Phone 86375 0
+61 3 9214 8930
Fax 86375 0
Email 86375 0
[email protected]
Contact person for scientific queries
Name 86376 0
Prof Andrew B Scholey, PhD
Address 86376 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 86376 0
Australia
Phone 86376 0
+61 3 9214 8932
Fax 86376 0
Email 86376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the data collected for this study will be published in peer reviewed journals and presented at conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.