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Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement.
The objective of this study is to investigate the effect of a Standardized botanical blend rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in healthy students. Moreover, in order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.
The study design will be a double-blind, randomised, placebo controlled, crossover study. A total of 30 healthy volunteers will be included. Each participant will receive a single dose of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced order. There will be a 1 week washout period between the 2 experimental visits. During each experimental visit, after a training battery volunteers will be administered a cognitive test battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90 min post-dose to 160 min post-dose).
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Inclusion criteria
Graduate students (being either at the University or high school), with exam at least every 6 months and attending courses at the equivalent of at least 2 full days each week;
Male and female subjects (at least 25% of each gender);
Subjects aged 18 - 25 years (limits included);
French native speaker;
Healthy, and especially not suffering from the following diseases, either medically controlled or not:
Not consuming any food supplements (at time of V0 visit) and agreeing not to consume any food supplements until the end of the study;
No consumption within the last 30 days (30 days before the V0 visit) of drug or food supplement likely to affect the studied parameters,
Body Mass Index (BMI) < 30 kg/m2;
Non-smoker;
No use of narcotics nor cannabis within the last 7 days (the 7 days preceding the V0 visit) and agreeing not to consume such products until the end of the study. The compliance with this criteria will be confirmed by a urine TetraHydroCannabinol (THC) test at the beginning of the testing visits (V1 and V2);
Subjects capable of and willing to comply with the protocol and to give their written informed consent.
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30 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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