Chronic Resveratrol Supplementation in Healthy Humans

Phase 1

Completed

Conditions: Healthy

Interventions: Dietary Supplement: Resveratrol
Other: Placebo

Registration Number: NCT01640197

Lead Sponsor: Northumbria University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500mg resveratrol	Resveratrol	Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Placebo	Placebo	Methyl Cellulose administered in identical capsules as the active.

Primary Outcome Measures

Name	Time	Method
Chronic Modulation of Cerebral Blood Flow	40- 80 minutes post- dose on day 28 of supplementation	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Modulated Mood	28 days	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.
Number of Participants With Modulated Cognitive Performance	28 days	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.
Number of Participants With Significant Modulation of Sleep	Day 28	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).
Number of Participants With Significant Modulation of Health	Day 28	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.
Number of Participants With Significant Modulation of Blood Pressure	28 days	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).
Number of Participants With Significant Modulation of CBF in MCA	28 days	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).