InflammationMUresvNCT01244360
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
A study testing resveratrol in people with Inflammation, run by Marywood University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women between 45 and 75 years of age
- Normal heart rate and Blood pressure
- Ability to use personal computer interface
- Successful completion of physical activity readiness questionnaire
Who cannot join
- Cardiovascular disease, uncontrolled hypertension, lung disease
- inability to tolerate exercise
- have taken grape related supplement in past 12 months
- current use of drugs or dietary supplements to enhance exercise performance
- allergy to wine, grape juice or grape seed supplements
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.
Read the detailed description
Measurements
- blood laboratory parameters
- cognitive assessment changes
- body composition changes
- vascular endothelial response
- Conditions
- Inflammation
- Being tested
- resveratrol, Placebo Comparator: Sugar Pill
- Keywords
- resveratrol, insulin, inflammation, cognition, metabolism
- Medical subject headings
- Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDietary supplement
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
Placebo Comparator: Sugar PillOther
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period. Receives: Other: Placebo Comparator: Sugar Pill |
| Dietary Supplement: resveratrol | Active comparator | Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period. Receives: Dietary Supplement: resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
vascular response to stress will be measured using flow mediated dilation and ultrasound.
Measured: 4 weeks, with option of additional 4 week treatment period
Secondary outcomes (3)
Body fat percentage
Body fat percentage will be measured using a DEXA scan.
Measured: 4 weeks, with optional additional 4 week treatment period
inflammation biomarkers
Fasting blood draw
Measured: 4 weeks, with optional additional 4 week treatment period
cognitive function
cognitive function will be assessed using a validated computer based assessment tool
Measured: 4 weeks, with optional additional 4 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marywood University
- Sponsor type
- University, hospital or other
- Investigators
- James Smoliga, Ph.D., Principal investigator, Marywood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244360
- Sponsor's protocol ID
- MU Smoliga Resveratrol
- Other IDs
- 2RESMU194218
- Acronym
- MUresv
- Status last verified
- Jun 2011
- First submitted
- 17 Nov 2010
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
- ClinicalTrials.gov ID
- NCT01244360
- Acronym / sponsor ID
- MUresv / MU Smoliga Resveratrol
- Conditions
- Inflammation
- Keywords
- resveratrol, insulin, inflammation, cognition, metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marywood UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.
Detailed description
Measurements
- blood laboratory parameters
- cognitive assessment changes
- body composition changes
- vascular endothelial response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Placebo Comparator: Sugar PillSubject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period. |
| Dietary Supplement: resveratrol | Active comparator | Dietary Supplement: resveratrolSubject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women between 45 and 75 years of age
- Normal heart rate and Blood pressure
- Ability to use personal computer interface
- Successful completion of physical activity readiness questionnaire
Key exclusion criteria (5 listed)
- Cardiovascular disease, uncontrolled hypertension, lung disease
- inability to tolerate exercise
- have taken grape related supplement in past 12 months
- current use of drugs or dietary supplements to enhance exercise performance
- allergy to wine, grape juice or grape seed supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resveratrolSubject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period. | Dietary supplement | Dietary Supplement: resveratrol |
| Placebo Comparator: Sugar PillSubject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period. | Other | Sugar Pill |
Primary outcome
Vascular function
Time frame: 4 weeks, with option of additional 4 week treatment period
vascular response to stress will be measured using flow mediated dilation and ultrasound.
3 secondary outcomes
Body fat percentage
Time frame: 4 weeks, with optional additional 4 week treatment period
inflammation biomarkers
Time frame: 4 weeks, with optional additional 4 week treatment period
cognitive function
Time frame: 4 weeks, with optional additional 4 week treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Smoliga, Ph.D. principal investigator
Marywood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resveratrol in people with Inflammation, run by Marywood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function (time frame: 4 weeks, with option of additional 4 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.