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

NCT03508206 | Completed DMC

• 1 other identifier: STUAI2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Students, cognitive functions, memory

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in the number of correct answers during the Serial Three Subtraction task (Serial Three) between the baseline battery and the 4th repetition of the battery after product intake (B4).

  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).

  From baseline to 120 min post-dose

Secondary Outcomes (17)

• Changes in the number of correct responses from the Serial Three Subtraction task between the baseline battery and each of the repetitions N°1, 2, 3, 5 and 6 of the battery after product intake

  From baseline to 160 min post-dose

• Changes in the number of correct responses from the Serial Three Subtraction task between the first repetition after product intake and the repetitions N°2 to 6

  From 90 to 160 min post-dose

• Changes in the number of errors from the Serial Three Subtraction task (Serial Three, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);

  From baseline to 160 min post-dose

• Changes in the number of correct responses from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);

  From baseline to 160 min post-dose

• Changes in the number of errors from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);

  From baseline to 160 min post-dose

Study Arms (2)

SBRP arm

EXPERIMENTAL

Food supplement in hard gelatin capsule form containing a Standardized botanical blend rich in polyphenols (SBRP)

Dietary Supplement: SBRP

Placebo arm

PLACEBO COMPARATOR

Hard gelatin capsule form containing maltodextrin, with the same appearance as SBRP capsules

Dietary Supplement: PLACEBO

Interventions

SBRP DIETARY_SUPPLEMENT

SBRP capsules

SBRP arm

PLACEBO DIETARY_SUPPLEMENT

Placebo capsules

Placebo arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• depression,
• anxiety disorders,
• diabetes (type I or type II),
• dyslipidemia,
• hypertension,
• any other cardiovascular disease,
• disorder of the thyroid function.
• 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;

You may not qualify if:

• Exam during the study period;
• Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg during the V0 visit;
• Currently suffering from or personal history of psychiatric or neurologic disorders (examples: schizophrenia, depression, generalized anxiety disorder, epilepsia) according to the subject's self-declaration;
• Neuroleptic, hypnotic, anxiolytic or antidepressant treatment (whatever the reason) ongoing or stopped since less than 3 months;
• Anti-hypertensive, blood thinner or anticoagulant treatment (eg aspirin \> 325mg / day and prescribed as anticoagulant) ongoing or stopped since less than 3 months;
• Venotonic treatment or vasodilator treatment ongoing or stopped since less than 3 months;
• Any other treatment (administered systemically or locally) that may affect the endothelial function (example: statins);
• History of moderate to severe traumatic brain injury and / or intracranial surgery;
• Personal history of Cerebrovascular Accident (CVA);
• Inflammatory bowel disease (examples: Crohn disease, coeliac disease, irritable bowel syndrome) likely to affect the intestinal absorption of the study product components;
• Progressive disease ongoing or resolved since less than one year;
• General anesthesia in the last 7 days or planned in the next 2 weeks;
• Restrictive or unbalanced diet (hypocaloric diet aiming at weight loss, vegan, …) according to the subject's self-declaration at V0;
• Excessive alcohol consumption : more than 2 glasses per day every day;
• Documented food allergy to one of the components of the study product;

Sponsors & Collaborators

• Activ'inside: lead
• CIC SANPSY (USR CNRS 3413), Hôpital Pellegrin, Bordeaux, FRANCE: collaborator
• Hospital St André, Bordeaux, FRANCE: collaborator

Study Sites (1)

SANPSY (CHU Pellegrin)

Bordeaux, 33076, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: November 13, 2017
• Primary Completion: May 3, 2018
• Study Completion: July 31, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)