Status:
COMPLETED
Effect of Resvida, a Comparison With Calorie Restriction Regimen
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
DSM Nutritional Products, Inc.
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
FEMALE
35-70 years
Phase:
NA
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00823381
Start Date
January 1 2009
End Date
December 1 2010
Last Update
December 10 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110