Use of Herbal Supplements in Weight Loss and Weight Maintenance

NCT00198809 | Terminated

• 1 other identifier: WELL2001-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• weight

• blood pressure

• pulse

• blood

Secondary Outcomes (2)

• psychometrics

• body composition

Interventions

Biolean + Diet education DRUG

Biolean Free + Diet education DRUG

Placebo + Diet education DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Wellness International, Ltd.: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2002
• Study Completion: February 1, 2004
• Last Updated: September 20, 2005

Record last verified: 2004-04

Locations

US (1)