ObesityResvidaNCT00823381
Effect of Resvida, a Comparison With Calorie Restriction Regimen
A study testing resveratrol and Calorie Restriction in people with Obesity and Metabolic Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of the antioxidant "resveratrol" to a diet intervention (Calorie Restriction) to determine how each of them affects the following: gene expression profile, cholesterol (lipids), how well the hormone insulin works to control your blood sugar, and other blood and… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Diabetes
- What is being tested?
- resveratrol and Calorie Restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal females (at least 1 year since last spontaneous menstrual bleeding)
- Caucasian
- Weight (defined as BMI): ≥ 20kg/m2 and < 30 kg/m2.
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements with specific agreement to a measurement of global gene expression profiles
- Subjects with the ability to comprehend and complete forms in English
- Subjects who are likely to comply with study procedures
- Subjects who are willing to be assigned to the Resveratrol or CR or Placebo intervention
Who cannot join
- History of serious or unstable medical or psychiatric disorders (e.g. diabetes, metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, musculoskeletal, or cancer) that, in the opinion of the investigator, would make the candidate ineligible for the study.
- History of major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
- Subjects with any allergic reaction or sensitivity to grape products or any component of the test article
- Subjects who are allergic to lidocaine
- Subjects currently on a low-calorie diet, a weight control or maintenance program, or those who practice a vegetarian or vegan diet
- Subjects who engage in programmed exercise > 2 hours total per week
Show all 13Show fewer
- Subjects who are smoking or stopped smoking within the past 6 months
- Subjects who have lost or gained >5 kg over the past six months
- Subjects on any other clinical trial or experimental treatment within the past 3 months
- Intake of dietary supplements except vitamins and minerals
- Unwilling to restrict high resveratrol-containing foods
- Current alcohol consumption >20 grams/day
- Current use of the following medications: weight loss medications (prescription or over-the-counter), beta-blockers, steroids, anticoagulants, any other medications that, in the opinion of the investigator, may compromise the validity or safety of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen
The purpose of this study is to compare the effects of the antioxidant "resveratrol" to a diet intervention (Calorie Restriction) to determine how each of them affects the following: gene expression profile, cholesterol (lipids), how well the hormone insulin works to control your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly extending lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant "resveratrol". Resvida™ will be supplied by DSM Nutritional Products, Ltd.
Read more
Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The makers of Resvida™ make no claim that this supplement is meant to treat any ailment.
Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.
This study is designed to compare the health benefits of both resveratrol and CR and to determine if resveratrol mimics some of the health benefits shown with CR.
- Conditions
- Obesity, Metabolic Syndrome, Diabetes, Aging
- Being tested
- resveratrol, placebo, Calorie Restriction
- Keywords
- obesity, metabolic syndrome, diabetes, aging, calorie restriction, resveratrol, antioxidant
- Medical subject headings
- Obesity, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDietary supplement
Also called Resvida™
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
placeboOther
one placebo pill taken once a day with breakfast
Calorie RestrictionBehavioural
supervised calorie restriction diet: 30% reduction in caloric intake
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Not described Receives: Dietary Supplement: resveratrol |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
| Calorie Restriction | Active comparator | Not described Receives: Behavioral: Calorie Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
global skeletal muscle gene expression profile
Measured: three months
Secondary outcomes (4)
insulin sensitivity
Measured: three months
intrahepatic triglyceride content, body composition
Measured: three months
blood lipid levels, markers of inflammation and plasma hormones
Measured: three months
safety and tolerability
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823381
- Sponsor's protocol ID
- 2007-09-25-RESV
- Acronym
- Resvida
- Status last verified
- Dec 2013
- First submitted
- 13 Jan 2009
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen
- ClinicalTrials.gov ID
- NCT00823381
- Acronym / sponsor ID
- Resvida / 2007-09-25-RESV
- Conditions
- Obesity, Metabolic Syndrome, Diabetes, Aging
- Keywords
- obesity, metabolic syndrome, diabetes, aging, calorie restriction, resveratrol, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jan 2009 (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 compare the effects of the antioxidant "resveratrol" to a diet intervention (Calorie Restriction) to determine how each of them affects the following: gene expression profile, cholesterol (lipids), how well the hormone insulin works to control your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly extending lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant "resveratrol". Resvida™ will be supplied by DSM Nutritional Products, Ltd.
Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The makers of Resvida™ make no claim that this supplement is meant to treat any ailment.
Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.
This study is designed to compare the health benefits of both resveratrol and CR and to determine if resveratrol mimics some of the health benefits shown with CR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: resveratrol |
| Placebo | Placebo comparator | Other: placebo |
| Calorie Restriction | Active comparator | Behavioral: Calorie Restriction |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post-menopausal females (at least 1 year since last spontaneous menstrual bleeding)
- Caucasian
- Weight (defined as BMI): ≥ 20kg/m2 and < 30 kg/m2.
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements with specific agreement to a measurement of global gene expression profiles
- Subjects with the ability to comprehend and complete forms in English
Key exclusion criteria (13 listed)
- History of serious or unstable medical or psychiatric disorders (e.g. diabetes, metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, musculoskeletal, or cancer) that, in the opinion of the investigator, would make the candidate ineligible for the study.
- History of major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
- Subjects with any allergic reaction or sensitivity to grape products or any component of the test article
- Subjects who are allergic to lidocaine
- Subjects currently on a low-calorie diet, a weight control or maintenance program, or those who practice a vegetarian or vegan diet
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 |
|---|---|---|
| resveratrolAlso: Resvida™one pill of resveratrol (Resvida™) 75 mg once a day with breakfast | Dietary supplement | Resveratrol |
| placeboone placebo pill taken once a day with breakfast | Other | Placebo |
| Calorie Restrictionsupervised calorie restriction diet: 30% reduction in caloric intake | Behavioural | Calorie Restriction |
Primary outcome
global skeletal muscle gene expression profile
Time frame: three months
4 secondary outcomes
insulin sensitivity
Time frame: three months
intrahepatic triglyceride content, body composition
Time frame: three months
blood lipid levels, markers of inflammation and plasma hormones
Time frame: three months
safety and tolerability
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
Samuel Klein, M.D. principal investigator
Washington University School of Medicine
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 and Calorie Restriction in people with Obesity and Metabolic Syndrome, run by Washington University School of Medicine 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 10 Dec 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
global skeletal muscle gene expression profile (time frame: three months). 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 10 Dec 2013.