Randomized clinical trial investigating effects of a multi-nutrient combination on mood, stress, sleep and cognition in healthy young adults
- Conditions
- Cognitive FunctionSleep qualityCerebral Blood FlowStressOxidative StressMental Health - Studies of normal psychology, cognitive function and behaviour
- Registration Number
- ACTRN12611000092998
- Lead Sponsor
- Swisse Vitamins Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method