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View Clinical Trial (Medical Research Study)
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Effect of Resvida, a Comparison With Calorie Restriction Regimen - NCT00823381-63110 (Clinical Trial 264094)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy264094.aspx
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| City: |
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St. Louis |
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State:
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MO |
| Zip Code: |
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63110 |
| Conditions: |
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Obesity - Metabolic Syndrome - Diabetes - Aging |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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. |
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| Study is available at: |
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Washington University School of Medicine
St. Louis, MO 63110
United States
Primary Contact:
Emily Jenkerson, B.A.
Email: jenkersone@msnotes.wustl.edu
Phone: 314-362-1000
Secondary Contact:
Emily Jenkerson, B.A.
Email: jenkersone@msnotes.wustl.edu
Phone: 314-362-1000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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