RecruitingACTRN12611000092998

Randomized clinical trial investigating effects of a multi-nutrient combination on mood, stress, sleep and cognition in healthy young adults

Sponsor

Swisse Vitamins Pty Ltd

Enrollment

160 participants

Start Date

Feb 1, 2011

Study Type

Interventional

Conditions

Cognitive Function Stress Oxidative Stress Cerebral Blood Flow

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.

Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking a daily multivitamin and multi-nutrient supplement for four months can improve mood, reduce stress, improve sleep, and sharpen thinking in healthy young adults. Participants are randomly assigned to take either the supplement or a look-alike placebo (dummy pill) and are tested at the start, after 2 months, and after 4 months. A smaller group will also do weekly tests at home on a mobile phone and have brain activity (brainwave) recordings taken. You may be eligible if: - You are a healthy non-smoking male or female between 25 and 45 years old - You are employed at least part-time or studying in higher education or TAFE - You have no history of anxiety, depression, psychiatric disorders, or epilepsy - You have no history of heart disease, high blood pressure, or diabetes - You are not currently taking any medications, vitamin supplements, herbal products, or illicit drugs that could affect mood or thinking - You are not pregnant or trying to become pregnant - You have no gluten or wheat allergy - You are willing to provide blood samples during the study You may NOT be eligible if: - You smoke cigarettes - You drink heavily (more than 2 standard drinks per day on average) - You have been diagnosed with diabetes, heart disease, or high blood pressure - You have a history of anxiety, depression, psychiatric disorders, or epilepsy - You have kidney, liver, or serious digestive problems - You have had a head injury or stroke - You are currently taking Warfarin - You are participating in another clinical trial Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.