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| Name | Class |
|---|---|
| Biotivia Longevity Bioceuticals | UNKNOWN |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Methyl Cellulose administered in identical capsules as the active. |
|
| 500mg resveratrol | Active Comparator | Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | Transmax (Biotivia). 500mg (1 capsule) per day for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 40- 80 minutes post- dose on day 28 of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O Kennedy, Professor | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain performance and nutrition research centre, Northumbria university | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
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.
All participants were recruited opportunistically from Northumbria University via spam email and posters around campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2. | Posted | Number | Participants | 40- 80 minutes post- dose on day 28 of supplementation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Wightman | Northumbria University | (+44) 0191 2437253 | emma.l.wightman@northumbria.ac.uk |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Other | Methyl Cellulose. 1 capsule taken once daily for 28 days. |
|
| 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. | 28 days |
| 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). | Day 28 |
| 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. | Day 28 |
| 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). | 28 days |
| 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). | 28 days |
Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days.
|
|
|
| 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. | Participants were included in the final analysis if they had completed all questionnaires correctly. | Posted | Number | Participants | 28 days |
|
|
|
|
| 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. | All participants who properly completed all repetitions of all tasks on both days were included in the analysis. | Posted | Number | Participants | 28 days |
|
|
|
|
| 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). | All participants who completed their questionnaires correctly were included in the analysis. | Posted | Number | Participants | Day 28 |
|
|
|
|
| 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. | Participants were included in the analysis if they had completed questionnaires correctly. | Posted | Number | Participants | Day 28 |
|
|
|
|
| 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). | All participants who provided all BP readings across the study were included in the analysis. | Posted | Number | Participants | 28 days |
|
|
|
|
| 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). | All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis. | Posted | Number | Participants | 28 days |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Methyl Cellulose administered in identical capsules as the active. Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days. | 0 | 30 | 0 | 30 |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |