Effect of High-Dose-Vitamin-B Multivitamin Supplement on Neural Connectivity and Oxidative Metabolism in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled, Phase I Clinical Trial

Taylor's University0 个研究点目标入组 90 人开始时间: 2022年8月22日最近更新: 2022年8月29日

适应症

试验速览

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•Healthy non-smoking males and females aged between 30 and 55 years
•Not heavy consumers of alcohol (i.e., females consumed < 14 standard drinks per week, males consumed < 28 standard drinks per week)
•No history of psychiatric disorders including clinical depression, anxiety or epilepsy
•No history of / do not currently suffer from heart disease or high blood pressure or diabetes
•Free from cognitive and memory impairment and does not suffer from any neurological disorders
•Not taking any form of vitamin, mineral, herbal supplement, medications or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) the study such as multivitamins, B vitamins, Ginkgo biloba, antioxidants or other supplements
•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
•No clinically relevant abnormalities in their medical history that would render them ineligible for MRI
•Not pregnant or possibility of being pregnant

•Gluten intolerance
•Having claustrophobia (fear of constrained space)
•History of head injury/stroke
•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
•Clinically relevant abnormalities in their medical history that would render them ineligible for MRI
•Currently taking Warfarin
•Having metallic implants and other abnormalities in their medical history that would render them ineligible for MRI

发起方

Taylor's University