Healthy
Conditions
Keywords
Cognitive performance, Cerebral blood flow, Subjective sleep, Subjective mood, Subjective health
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.
Interventions
DIETARY_SUPPLEMENTResveratrol
Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.
OTHERPlacebo
Methyl Cellulose. 1 capsule taken once daily for 28 days.
Sponsors
Biotivia Longevity Bioceuticals
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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). |
| 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). |
Countries
United Kingdom
Participant flow
Recruitment details
All participants were recruited opportunistically from Northumbria University via spam email and posters around campus.
Pre-assignment details
Before participants were enrolled they were required to complete a training/screening session. If they met the study exclusion criteria or did not perform within the cognitive task norms (compiled from previous studies) then they were not eligible to take part in the study.
Participants by arm
| Arm | Count |
|---|---|
| 500mg Resveratrol Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days. | 30 |
| Placebo Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo | 500mg Resveratrol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age Continuous | 20.00 years STANDARD_DEVIATION 2.32 | 21.04 years STANDARD_DEVIATION 2.01 | 20.52 years STANDARD_DEVIATION 2.17 |
| Region of Enrollment United Kingdom | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 40- 80 minutes post- dose on day 28 of supplementation
Population: Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Chronic Modulation of Cerebral Blood Flow | 0 Participants |
| Placebo | Chronic Modulation of Cerebral Blood Flow | 0 Participants |
p-value: >0.05ANOVA
Secondary
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.
Time frame: 28 days
Population: All participants who properly completed all repetitions of all tasks on both days were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Modulated Cognitive Performance | 0 Participants |
| Placebo | Number of Participants With Modulated Cognitive Performance | 0 Participants |
p-value: >0.05ANOVA
Secondary
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.
Time frame: 28 days
Population: Participants were included in the final analysis if they had completed all questionnaires correctly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Modulated Mood | 0 Participants |
| Placebo | Number of Participants With Modulated Mood | 0 Participants |
p-value: >0.05ANOVA
Secondary
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).
Time frame: 28 days
Population: All participants who provided all BP readings across the study were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Significant Modulation of Blood Pressure | 0 Participants |
| Placebo | Number of Participants With Significant Modulation of Blood Pressure | 0 Participants |
p-value: >0.05ANOVA
Secondary
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).
Time frame: 28 days
Population: All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Significant Modulation of CBF in MCA | 0 Participants |
| Placebo | Number of Participants With Significant Modulation of CBF in MCA | 0 Participants |
p-value: >0.05ANOVA
Secondary
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.
Time frame: Day 28
Population: Participants were included in the analysis if they had completed questionnaires correctly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Significant Modulation of Health | 0 Participants |
| Placebo | Number of Participants With Significant Modulation of Health | 0 Participants |
p-value: >0.05ANOVA
Secondary
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).
Time frame: Day 28
Population: All participants who completed their questionnaires correctly were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500mg Resveratrol | Number of Participants With Significant Modulation of Sleep | 0 Participants |
| Placebo | Number of Participants With Significant Modulation of Sleep | 0 Participants |
p-value: >0.05ANOVA