Chronic Resveratrol Supplementation in Healthy Humans

Study Overview
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Brief Summary
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The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.

Official Title
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The Effects of Chronic Trans- Resveratrol Supplementation on Aspects of Cognitive Performance, Mood, Sleep, Health and Cerebral Blood Flow in Healthy, Young Humans.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Between 18-35 At least enrolled on undergraduate degree programme Native English speaker Exclusion Criteria: Smoking Taking other medication/ supplements Pregnant/ breast feeding High caffeine consumers Migraine sufferers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Methyl Cellulose administered in identical capsules as the active. | Other: Placebo<br>* Methyl Cellulose. 1 capsule taken once daily for 28 days.<br>|
| Active Comparator: 500mg resveratrol<br>Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily. | Dietary Supplement: Resveratrol<br>* Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Modulation of Cerebral Blood Flow | Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28. | 40- 80 minutes post- dose on day 28 of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Modulated Mood | Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1. | 28 days | 
| Number of Participants With Modulated Cognitive Performance | Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1. | 28 days | 
| Number of Participants With Significant Modulation of Sleep | Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline). | Day 28 | 
| Number of Participants With Significant Modulation of Health | Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion. | Day 28 | 
| Number of Participants With Significant Modulation of Blood Pressure | Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline). | 28 days | 
| Number of Participants With Significant Modulation of CBF in MCA | CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline). | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive performance, Cerebral blood flow, Subjective sleep, Subjective mood, Subjective health