Use of Herbal Supplements in Weight Loss and Weight Maintenance

NCT ID: NCT00198809

Last Updated: 2005-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2004-02-29

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 Free compared to each other and a matching placebo, in effects on appetite suppression, changes in metabolism, weight loss, and safety in overweight men and women over a 12 month active weight loss and weight maintenance program.
• This is a randomized double-blind study. The planned sample size is 180 healthy, overweight (BMI 27-40) males and females aged 18-60.

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 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Biolean + Diet education

Intervention Type: DRUG

Biolean Free + Diet education

Intervention Type: DRUG

Placebo + Diet education

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wellness International, Ltd.

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Principal Investigators

Lawrence J Cheskin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

WELL2001-01

Identifier Type: -

Identifier Source: org_study_id