Status:
TERMINATED
Use of Herbal Supplements in Weight Loss and Weight Maintenance
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Wellness International, Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Effects of herbal products on weight loss, weight maintenance and metabolic rate. * The objective of this study is to evaluate the efficacy of two herbal weight loss products, BioLean and BioLean Fre...
Detailed Description
• The study data collection will occur in two phases, active weight loss (phase 1) and weight maintenance (phase 2). Transition into phase 2 will be individually determined by participant attainment o...
Eligibility Criteria
Inclusion
- Between 18-60 years of age, overweight (Body Mass Index between 27-40) and desiring weight loss, normal EKG (electrocardiogram), not using or on a stable dosage of appetite- affecting medications (e.g., Prozac or other SSRIs, Synthroid, steroids), non-pregnant at screening by serum pregnancy test if female of childbearing capacity and using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile, willing and able to comply with the protocol requirements, willing and able to give informed consent, have a regular source of health care and permission of primary care provider.
Exclusion
- Chronic health problems (not including obesity, allergies, skin problems, or occasional GERD or IBS symptoms). Participant may not have bulimia or laxative abuse, substance abuse, or alcohol intake \> 10 oz. per week, or be under treatment for a psychiatric disorder (including depression, bipolar disorder, and anxiety determined by self-report during phone screening and the Beck Inventory survey to be completed during screening visit), as determined at screening. Use of ephedrine-containing products in the past 3 months, unwillingness to limit use of caffeinated beverages to three cups per day during participation in the study, active cigarette smoking of \> 1 cigarette per week, resting systolic blood pressure \> 140 mmHg or diastolic \> 90 mmHg or pulse \< 55 or \> 100, and if female pregnant or breast-feeding.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00198809
Start Date
November 1 2002
End Date
February 1 2004
Last Update
September 20 2005
Active Locations (1)
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1
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205