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Completed

NCT Number: NCT01640197

Chronic Resveratrol Supplementation in Healthy Humans

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.

Placebo

Other

Methyl Cellulose. 1 capsule taken once daily for 28 days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Biotivia Longevity Bioceuticals

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2012
Registry last updated
Oct 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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