Chronic Resveratrol Supplementation in Healthy Humans

This study has been completed.
Sponsor:
Collaborator:
Biotivia Longevity Bioceuticals
Information provided by (Responsible Party):
David Kennedy, Northumbria University
ClinicalTrials.gov Identifier:
NCT01640197
First received: July 10, 2012
Last updated: October 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: Resveratrol
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Chronic Modulation of Cerebral Blood Flow [ Time Frame: 40- 80 minutes post- dose on day 28 of supplementation ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With Modulated Mood [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Methyl Cellulose administered in identical capsules as the active.
Other: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640197

Locations
United Kingdom
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Biotivia Longevity Bioceuticals
Investigators
Principal Investigator: David O Kennedy, Professor Northumbria University
  More Information

No publications provided

Responsible Party: David Kennedy, Professor, Northumbria University
ClinicalTrials.gov Identifier: NCT01640197     History of Changes
Other Study ID Numbers: 22P4
Study First Received: July 10, 2012
Results First Received: September 11, 2012
Last Updated: October 17, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Cognitive performance
Cerebral blood flow
Subjective sleep
Subjective mood
Subjective health

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014