SANPSY (CHU Pellegrin)
Bordeaux, 33076, France
NCT Number: NCT03508206
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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Notify Me18 year–25 year
All sexes
Interventional
Not applicable
Bordeaux, 33076, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SBRP capsules
Placebo capsules
Time frame: From baseline to 120 min post-dose
The Serial Three task will be administered through the computerized COMPASS battery (" Computerised Mental Performance Assessment System "). Serial subtraction tasks rely on working memory (executive function).
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From 90 to 160 min post-dose
Differences between the values obtained during the first post-dose battery and the next repetitions;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: From baseline to 160 min post-dose
Differences between each battery and baseline values;
Time frame: 85-90 min post-dose
Number of words properly recalled, among a list of 20 words, with no clue
Time frame: 165-170 min post-dose
Number of words properly recalled, among a list of 20 words, with no clue
Time frame: 165-170 min post-dose
Number of words properly recognized among a list of 20 words containing 10 words from the original list and 10 distractors
Time frame: Before product administration; 180 min post-dose
Post-ischemic increase of brachial artery diameter, in % of the pre-ischemic diameter
Time frame: Before product administration; 180 min post-dose
Pre-ischemic diameter of brachial artery (mm)
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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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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