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| Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Wellness International, Ltd. |
|---|---|
| Information provided by: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00198809 |
Purpose
Effects of herbal products on weight loss, weight maintenance and metabolic rate.
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Biolean + Diet education Drug: Biolean Free + Diet education Drug: Placebo + Diet education |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Use of Herbal Supplements in Weight Loss and Weight Maintenance |
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | February 2004 |
• 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 of a goal ‘healthy’ weight. During the 52 weeks participants will pick up supplemental pills, have weight measured, and meet for educational meeting on an every other week basis. Upon entering phase 2, participants will have the option of educational sessions on a monthly basis or every other week. Participants will have a goal ‘healthy’ weight determined at baseline by a combination of personal goals, Harris Benedict Equation goals, body composition goals, and BMI range. All participants will be put on a weight reduction plan to reach these goals and be randomly assigned to one of 3 treatment groups, Biolean, Biolean Free, or Placebo. Since it is expected some participants will reach goal weight before others, the 2nd milestone data collection will occur at attainment of goal weight. To assure all participants have 3 data collection points, any participant who is not expected to reasonably reach their goal weight by 34 weeks will have the 2nd milestone data collection at 26 weeks. The 3rd milestone data collection for all participants is 52 weeks after initial intake of supplement. Upon attainment of goal weight and 2nd data collection point, participants will be educated on a weight maintenance plan and given a new meal plan to achieve long term healthy weight maintenance.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 Criteria:
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.
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Bloomberg School of Public Health | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Lawrence J Cheskin, MD | Johns Hopkins Bloomberg School of Public Health |
More Information
| Study ID Numbers: | WELL2001-01 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00198809 |
| Health Authority: | United States: Institutional Review Board |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |
