Use of Herbal Supplements in Weight Loss and Weight Maintenance

Obesity Clinical Trial

Official title:

Use of Herbal Supplements in Weight Loss and Weight Maintenance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00198809
• Other study ID #: WELL2001-01
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: November 2002
• Est. completion date: February 2004

Study information

• Verified date: April 2004
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Biolean + Diet education

• Biolean Free + Diet education

• Placebo + Diet education

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Wellness International, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight
Primary	blood pressure
Primary	pulse
Primary	blood
Secondary	psychometrics
Secondary	body composition