Trial Outcomes & Findings for Chronic Resveratrol Supplementation in Healthy Humans (NCT NCT01640197)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

40- 80 minutes post- dose on day 28 of supplementation

Results posted on

2012-10-19

Participant Flow

All participants were recruited opportunistically from Northumbria University via spam email and posters around campus.

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.

Participant milestones

Participant milestones
Measure	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.	Placebo Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Resveratrol Supplementation in Healthy Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	500mg Resveratrol n=30 Participants 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.	Placebo n=30 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	21.04 years STANDARD_DEVIATION 2.01 • n=5 Participants	20.00 years STANDARD_DEVIATION 2.32 • n=7 Participants	20.52 years STANDARD_DEVIATION 2.17 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United Kingdom	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=22 Participants 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.	Placebo n=24 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Chronic Modulation of Cerebral Blood Flow	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Participants were included in the final analysis if they had completed all questionnaires correctly.

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.

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=26 Participants 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.	Placebo n=28 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Modulated Mood	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: All participants who properly completed all repetitions of all tasks on both days were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=22 Participants 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.	Placebo n=19 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Modulated Cognitive Performance	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 28

Population: All participants who completed their questionnaires correctly were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=25 Participants 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.	Placebo n=28 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Significant Modulation of Sleep	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 28

Population: Participants were included in the analysis if they had completed questionnaires correctly.

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.

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=25 Participants 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.	Placebo n=28 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Significant Modulation of Health	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: All participants who provided all BP readings across the study were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=9 Participants 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.	Placebo n=15 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Significant Modulation of Blood Pressure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	500mg Resveratrol n=25 Participants 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.	Placebo n=21 Participants Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
Number of Participants With Significant Modulation of CBF in MCA	0 Participants	0 Participants

Adverse Events

500mg Resveratrol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emma Wightman

Northumbria University

Phone: (+44) 0191 2437253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place