NCT03508206

Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students

Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students: Randomized, Placebo-controlled, Double-blind, Cross-over Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Activ'inside · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SBRP	SBRP capsules
DIETARY_SUPPLEMENT	PLACEBO	Placebo capsules

Timeline

• Start date: 2017-11-13
• Primary completion: 2018-05-03
• Completion: 2018-07-31
• First posted: 2018-04-25
• Last updated: 2019-05-29

Locations

1 site across 1 country: France