Effect of Resvida, a Comparison With Calorie Restriction Regimen

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jan 13, 2009

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• 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.