Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000092998
Ethics application status
Approved
Date submitted
25/01/2011
Date registered
27/01/2011
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized clinical trial investigating effects of a multi-nutrient combination on mood, stress, sleep and cognition in healthy young adults
Scientific title
Randomized clinical trial investigating effects of a multi-nutrient combination on mood, stress, sleep and cognition in healthy young adults
Secondary ID [1] 253480 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 261030 0
Cerebral Blood Flow 261031 0
Stress 261032 0
Sleep quality 261033 0
Oxidative Stress 261034 0
Condition category
Condition code
Mental Health 259170 259170 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Swisse Women's Ultivite Multi-Vitamin Mineral & Anti-Oxidant with Herbs Formula 1 Dietary Supplement (ARTG Entry 134520) is taken by 40 women, and placebo is taken by 40 women. Swisse Men's Ultivite Multi-Vitamin Mineral & Anti-Oxidant with Herbs Formula 1 Dietary Supplement (ARTG Entry 134521) is taken by 40 men, and placebo is taken by 40 men. There are hence four treatment groups in total. For all treatment groups 1xTablet is taken daily over a 4 month (16 week) period. A subset of participants (20 females receiving placebo and 20 females receiving Ultivite, as well as 20 males receiving placebo and 20 males receiving Ultivite) will be given mobile phones for weekly cognitive and mood testing from home. Another subset of participants (20 females receiving placebo and 20 females receiving Ultivite, as well as 20 males receiving placebo and 20 males receiving Ultivite) will have EEG/SST brainwave recording at each of the study visits baseline, 2 months and 4 months.
Intervention code [1] 257915 0
Prevention
Intervention code [2] 257921 0
Treatment: Other
Comparator / control treatment
Placebo, is identical to the active treatments in terms of taste and appearance, but does not contain any of the active ingredients
Control group
Placebo

Outcomes
Primary outcome [1] 262022 0
General Health Questionnaire (GHQ)
Timepoint [1] 262022 0
Baseline, 2 months, 4 months.
Secondary outcome [1] 268962 0
Other cognitive tasks:
Swinburne University Cognitive Ageing Battery (SUCCAB)
Purple Multitasking Framework
Arrow Flankers
Timepoint [1] 268962 0
Baseline, 2 months, 4 months.
Secondary outcome [2] 268963 0
Mood/Stress questionnaires:
Profile of Mood States (POMS)
Bond-Lader Visual Analogue Scales - subjective measure of mood and alertness
Visual Analogue scales for Stress, Concentration, Fatigue (Mental/Physical) and Anxiety
State Anxiety (STAI)
Occupational Stress Inventory (OSI)
Chalder Fatigue Scale
Timepoint [2] 268963 0
Baseline, 2 months, 4 months.
Secondary outcome [3] 268964 0
Cerebral Blood flow (using transcranial doppler ultrasound) and Artierial Stiffness (using Sphygmocor)
Timepoint [3] 268964 0
Baseline, 2 months, 4 months.
Secondary outcome [4] 268965 0
Blood measures:
Homocysteine, Cytokines, C-Reactive Protein, Brain Derived Neurotrophic Factor (BDNF), Telomere Length, Total Triglycerides, High-density Lipoprotein (HDL), Low-Density Lipoprotein (LDL).
Timepoint [4] 268965 0
Baseline, 2 months, 4 months.
Secondary outcome [5] 268966 0
Pittsburgh Sleep Quality Index
Timepoint [5] 268966 0
Baseline, 2 months, 4 months.
Secondary outcome [6] 268967 0
Saliva Cortisol - measure of chronic stress
Timepoint [6] 268967 0
Baseline, 2 months, 4 months (4 measurements taken on the day preceeding each study visit to track diurnal changes in cortisol secretion
Secondary outcome [7] 268969 0
Cognitive Tests on Mobile Phones
Timepoint [7] 268969 0
A subset of participants (40 females and 40 males) will take home mobile phones and complete cognitive and mood tests once a week (16 timepoints in total).
The cognitive tests include: Serial Sevens, Little Man (mental rotation) and Associative Learning. The mood scales include the Bond-Lader Visual-Analogue scale as well as visual analogue scales of Stess, concentration, fatigue (mental/physical) and anxiety.
Secondary outcome [8] 268986 0
Steady State Probe Topography (SST) brainwave recording.
Timepoint [8] 268986 0
A subset of pariticipants (40 females and 40 males) will have their brainwaves (EEG) recorded using the SST electrophysiological recording technique. This will occur at baseline, 2 months and 4 months.

Eligibility
Key inclusion criteria
1. Healthy non-smoking males and females aged between 25 and 45 years.

2. Currently in at least part-time employment and/or a student in higher education or TAFE.

3. No history of anxiety, depression, psychiatric disorders or epilepsy

4. No history of / do not currently suffer from heart disease or high blood pressure or diabetes.

5. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) study.

6. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study

7. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)

8. Not pregnant or possibility of being pregnant

9. No hearing impairment

10. Not allergic to gluten/wheat

11. Are willing and able to participate in all scheduled visits, treatment plan, dietary restrictions, tests and other trial procedures according to the protocol. Also comfortable with computers.

12. Are willing to provide blood samples throughout the testing phases

13. Understand the rating scales and computer tests (as judged by the study coordinator)

14. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Cigarette smoker

2. Heavy drinker of alcohol (averages more than 2 standard drinks per day).

3. Diagnosis of Type 1 or Type 2 diabetes

4. History of anxiety, depression, psychiatric disorders or epilepsy

5. History of / currently suffers from heart disease or high blood pressure.

6. Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years

7. Use of any over-the-counter herbal extracts, vitamin supplements and/or other dietary supplements which might influence cognition or mood for four weeks prior to the practice day

8. Currently taking any illicit drugs and/or a history of substance abuse.

9. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. have Irritable bowel syndrome, peptic ulcers)

10. Pregnant or possibility of being pregnant

11. Allergy to gluten/wheat

12. Hearing impairment

13. Are not willing to provide blood samples throughout the testing phases

14. Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day.

15. History of head injury/stroke

16. Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests.

17. Currently taking Warfarin

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)
Participants will respond to advertisements and pass a phone screen before coming in for their screening and enrolment. Participants will be allocated a participant number that will be assigned to a treatment code. Participants in male and female groups will be randomly allocated to either active or placebo using a computerised random number generator. The products used in this study will be coded A and B for females or C and D for males. The person who determined if a participant was eligible for inclusion in the trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation was concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated a participant number that will be assigned to a treatment code. Participants in male and female groups will be randomly allocated to either active or placebo using a computerised random number generator.The products used in this study will be coded (A, B, C and D).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a chronic, placebo-controlled, double-blind, randomized, single centre, clinical trial with 2 treatment groups for females: Women's Ultivite F1 or placebo, and 2 treatment groups for males: Men's Ultivite F1 or placebo.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258392 0
Commercial sector/Industry
Name [1] 258392 0
Swisse Vitamins Pty Ltd
Country [1] 258392 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Vitamins Pty Ltd
Address
36-38 Gipps Street
Collingwood, Victoria,
3066
Country
Australia
Secondary sponsor category [1] 257533 0
None
Name [1] 257533 0
Address [1] 257533 0
Country [1] 257533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260367 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 260367 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 260367 0
Australia
Date submitted for ethics approval [1] 260367 0
Approval date [1] 260367 0
03/12/2010
Ethics approval number [1] 260367 0
SUHREC 2010/261

Summary
Brief summary
Participants attend Swinburne University Hawthorn for one practice visit where they go through the screening questions and provide informed consent. They also practice all cognitive and mood tasks that they will be doing on their subsequent testing sessions. They are then randomised to receive either the multivitamin treatment or placebo for 4 months. Participants come in for 3 testing sessions, the first one week later (V1), the second 2 months later (V2) and the third and final visit after 4 months (V3). At each testing session they complete congitive and mood assessments, together with blood flow, arterial stiffness, saliva cortisol, sleep quality and blood biomarker assessments. A subset of participants (40 males and 40 females) will also complete weekly cognitive and mood tests from home using mobile phones provided. Another subset of participants (40 males and 40 females) will also complete Steady State Probe Topography (SST) brainwave recording at Baseline, V2 and V3.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32134 0
Address 32134 0
Country 32134 0
Phone 32134 0
Fax 32134 0
Email 32134 0
Contact person for public queries
Name 15381 0
Dr Andrew Pipingas
Address 15381 0
Centre for Human Psychopharmacology, Room 10.13, Advanced Technologies Centre (ATC) 427-451 Burwood Rd, Hawthorn, Victoria, 3122
Country 15381 0
Australia
Phone 15381 0
+61 3 9214-5215
Fax 15381 0
Email 15381 0
[email protected]
Contact person for scientific queries
Name 6309 0
Dr Andrew Pipingas
Address 6309 0
Centre for Human Psychopharmacology, Room 10.13, Advanced Technologies Centre (ATC) 427-451 Burwood Rd, Hawthorn, Victoria, 3122
Country 6309 0
Australia
Phone 6309 0
+61 3 9214-5215
Fax 6309 0
Email 6309 0
[email protected]

No information has been provided regarding IPD availability


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.

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