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

Swisse Vitamins Pty Ltd0 sites160 target enrollmentJanuary 27, 2011

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Swisse Vitamins Pty Ltd

•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

•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