None listed
Conditions
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.
Interventions
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 partic
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.
Sponsors
Swisse Vitamins Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed