Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000505505p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a novel fibre supplement improve gut symptoms and well-being in athletes and community members with gut complaints?
Scientific title
Can a novel fibre supplement improve gut symptoms and well-being in athletes and community members with gut complaints?
Secondary ID [1] 311546 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620000032954.

This study is a follow-up study from research findings of a previous randomized, double-blind controlled study conducted at Edith Cowan University in 2019. The main difference being that the current study is targeting athletic and community populations who suffer from gut discomfort. In addition to the previous study, gut transit time will be assessed as one of the indicators of gut health. The intervention is similar to the previous study.

Health condition
Health condition(s) or problem(s) studied:
Gut Health
 332862 0
Gut Microbiome 332864 0
Gut Transit Time 332865 0
Mental Health 332866 0
Dietary Fibre 332867 0
Condition category
Condition code
Diet and Nutrition 329581 329581 0 0
Other diet and nutrition disorders
Mental Health 329582 329582 0 0
Anxiety
Oral and Gastrointestinal 329583 329583 0 0
Normal oral and gastrointestinal development and function
Public Health 329584 329584 0 0
Health promotion/education
Metabolic and Endocrine 329585 329585 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline observation (week 0 )

At the first clinic visit, blood sample will be collected from participants by a certified phlebotomist, and their body weight and percentage of lean and fat mass will be obtained using the BOD POD® (Cosmed, Rome, Italy). Participants will also complete the questionnaires about GI symptoms, mental health and quality of life. To assess gut transit time, at the first clinic visit, participants will be asked to consume two blue muffins (provided) and the time will be recorded. They will then be asked to report the time of the bowel movement when they first note a blue-green colour in their stool. Participants will be educated to record their 3-day food diary via a free smart-phone application, Research Food Diary (Xyris, QLD, Australia). A stool kit and an instruction sheet will be provided to participants to collect their stool sample on the last day of the dietary record period.

Intervention (week 1 - week4)

After baseline (T1) assessments, participants will be provided a resealable bag of the fibre powder for the 4-week intervention phase along with recommended consumption methods, and scheduled consumption dosage. With regard to the fibre intervention, the 4-week period is scheduled as a 10-day ramping up from 5 g/d to 40 g/d, and full-serve for 11 days at 40 g/d, followed by a 7-day maintenance serve at 20 g/d.


Participants will be educated to divide the daily serve between breakfast and dinner, consuming as a beverage or within recommended recipes that avoid heating over 140 degrees. Participants will be required to maintain their habitual diet throughout the study and complete weekly GI symptom questionnaires before attending a final clinic visit for the T2 assessments. At the end of the intervention, participants will be asked to attend the final clinic visits to repeat the measurements assessed at the first visits. Participants will be asked to return any unused portion of the fibre powder provided, which will be weighed to calculate the total quantity of consumption.


The fibre powder

The dietary fibre powder is a mixture of dietary fibres, developed by researchers at Edith Cowan University, which also assisted study participants to meet Australian Dietary Guideline recommendations for fibre (Yan, 2023). This study was conducted at ECU (School of Medical and Health Science).
Intervention code [1] 327971 0
Treatment: Other
Intervention code [2] 327972 0
Lifestyle
Comparator / control treatment
No control group.

Due to the limitation of the time and budget, the two groups will have the same intervention with no control group. The difference of the participants in the two groups is the physical activity level. As the inclusion criteria outline, the athlete group will comprise endurance athletes, such as long-distance runners or triathletes, who will need to be currently following a periodised training plan that involves completing greater than 10 hours of training each week that incorporates at least one session lasting longer than 90 minutes. Whereas for community members, the study will recruit healthy adults who carry out < 3 hours per week of moderate and high intensity physical activity.


A direct comparison will be made between outcomes measured in the athlete group and outcomes measured in the community members.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337366 0
Gut symptoms 1
Timepoint [1] 337366 0
Baseline and weekly during the 4-week intervention, including the end of the intervention as end-of-study timepoint
Primary outcome [2] 337367 0
Whole gut transit time
Timepoint [2] 337367 0
Baseline and immediately after the 4-week intervention period.
Primary outcome [3] 337738 0
Gut symptoms 2
Timepoint [3] 337738 0
Baseline and weekly during the 4-week intervention, including the end of the intervention as end-of-study timepoint
Secondary outcome [1] 431596 0
Body fat ratio (body composition)
Timepoint [1] 431596 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [2] 431597 0
Blood pressure.
Timepoint [2] 431597 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [3] 431750 0
Faecal Short-Chain Fatty Acid
Timepoint [3] 431750 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [4] 431751 0
Mental health conditions (1)
Timepoint [4] 431751 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [5] 431753 0
Quality of life 1
Timepoint [5] 431753 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [6] 431754 0
Dietary intake
Timepoint [6] 431754 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [7] 431756 0
Blood Lipopolysaccharide
Timepoint [7] 431756 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [8] 431757 0
Gut microbiota
Timepoint [8] 431757 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [9] 431758 0
Physical activity/ Training load
Timepoint [9] 431758 0
For community members, baseline and immediately after the 4-week intervention period.
For athletic participants, on a daily basis from baseline until completion of the 4-week intervention period.
Secondary outcome [10] 431759 0
Diet quality assessment
Timepoint [10] 431759 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [11] 432975 0
Bowel movement frequency and stool form (stool consistency)
Timepoint [11] 432975 0
Baseline and weekly during the 4-week intervention, including the end of the intervention as end-of-study timepoint
Secondary outcome [12] 432978 0
circumferences of waist and hips
Timepoint [12] 432978 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [13] 432980 0
Body Mass Index(BMI)
Timepoint [13] 432980 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [14] 432994 0
Mental health conditions (2)
Timepoint [14] 432994 0
Baseline and immediately after the 4-week intervention period.
Secondary outcome [15] 432996 0
Quality of Life (2)
Timepoint [15] 432996 0
Baseline and immediately after the 4-week intervention period.

Eligibility
Key inclusion criteria
Inclusion criteria

Both groups of Community members and athletes:
1) Aged 18 - 65 years old;
2) Available to attend local clinic visits at ECU Joondalup and willing to consume the intervention dietary formula;
3) Have self-reported GI symptoms (mild to severe) within at least 3 months prior to the commencement of the study.

Community members:
1) Healthy adults with < 3 hours per week of moderate and high intensity physical activity (e.g. jogging, running, fitness classes in the gym, Pilates)

Athletes:
1). Be either a long-distance runner and/or triathlete and currently following a periodised training plan which, at peak, involved performing greater than 10 hours of training each week and including greater than 90 minutes endurance training each week.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current smoker
2) Pregnant or planning to become pregnant;
3) Breastfeeding;
4) Have a known diagnosis of other gastrointestinal illness (e.g. Inflammatory Bowel Disease, bowel resection, coeliac disease);
5) Previous abdominal or gastrointestinal surgeries that affect GI function and absorption;
6) Have been taking antibiotics in the past four weeks
7) Have been taking other medication to modify or treat chronic GI illness, or mental health conditions;
8) Renal or hepatic diseases, and/or other major medical illness, condition or habit that may interfere with completion of the study.
9) Have been under severe mental health conditions, which is indicated by the DASS-21, mental health questionnaire.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An a priori sample size for the proposed study was determined based on a default effect size (0.25, medium effect size) where a total sample size of 34 participants (17 per group) is required to detect a change in gut symptoms (measured by questionnaires Gastrointestinal Symptom Rating Scale (GSRS) (Dimenäs et al., 1996; Kulich et al., 2008) and a Modified Visual Analog Scale (mVAS) (Gaskell et al., 2019)) at 80% power and 5% level of significance. Allowing for a 15% drop-out rate, the total sample size of 40 subjects, 20 per group is required. The GSRS (Dimenäs et al., 1995) has 15 items with a 0-7 Likert scale that has been validated with available norm values for the general population (Dimenäs et al., 1996). The reliability of mVAS is well-documented to determine incidence and severity of GI symptoms in response to exercise stress (Gaskell et al., 2019).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315809 0
University
Name [1] 315809 0
Edith Cowan University
Country [1] 315809 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 317937 0
None
Name [1] 317937 0
Address [1] 317937 0
Country [1] 317937 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314667 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 314667 0
Ethics committee country [1] 314667 0
Australia
Date submitted for ethics approval [1] 314667 0
19/01/2024
Approval date [1] 314667 0
Ethics approval number [1] 314667 0
2023-04832-YAN

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132338 0
Dr Tina (Ran) Yan
Address 132338 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 132338 0
Australia
Phone 132338 0
+61 8 6304 5579
Fax 132338 0
Email 132338 0
[email protected]
Contact person for public queries
Name 132339 0
Tina (Ran) Yan
Address 132339 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 132339 0
Australia
Phone 132339 0
+61 8 6304 5579
Fax 132339 0
Email 132339 0
[email protected]
Contact person for scientific queries
Name 132340 0
A/Prof Claus T Christophersen
Address 132340 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 132340 0
Australia
Phone 132340 0
+61 8 63045278
Fax 132340 0
Email 132340 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
This is patentable, we disclose it due to commercial confidentiality.


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.