Chronic Resveratrol Supplementation in Healthy Humans
|ClinicalTrials.gov Identifier: NCT01640197|
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : October 12, 2012
Last Update Posted : October 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Resveratrol Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Chronic Trans- Resveratrol Supplementation on Aspects of Cognitive Performance, Mood, Sleep, Health and Cerebral Blood Flow in Healthy, Young Humans.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Placebo Comparator: Placebo
Methyl Cellulose administered in identical capsules as the active.
Methyl Cellulose. 1 capsule taken once daily for 28 days.
Active Comparator: 500mg resveratrol
Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Dietary Supplement: Resveratrol
Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.
- Chronic Modulation of Cerebral Blood Flow [ Time Frame: 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.
- Number of Participants With Modulated Mood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640197
|Brain performance and nutrition research centre, Northumbria university|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST|
|Principal Investigator:||David O Kennedy, Professor||Northumbria University|