NCT00613600

Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

Safety and Efficacy of Glucomannan for Weight Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Overweight and obesity are serious and growing problems within the United States. The usual approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a fiber supplement that has promising weight loss effects.

Detailed description

The primary objective of this exploratory project is to evaluate the safety and efficacy of a highly viscous, water-soluble fiber supplement, glucomannan, for achieving weight loss in overweight and moderately obese individuals. Overweight and obesity are major public health problems in the U.S. that account for substantial morbidity, mortality, and healthcare costs. Conventional approaches to weight loss are largely ineffective, particularly for long-term weight loss and maintenance. Thus, there is a critical need for safe and effective adjunctive treatments. A few, limited studies suggest that glucomannan supplementation is associated with weight loss, is well-tolerated, and has a favorable safety profile. In this preliminary study, the target population will be overweight and moderately obese individuals, a population that accounts for nearly 50% of all U.S. adults. The specific aims of the project are to: 1) describe the safety of glucomannan for achieving weight loss in overweight and moderately obese individuals, and 2) describe the efficacy of glucomannan for achieving weight loss in overweight and moderately obese individuals. Participants will take glucomannan supplements daily for eight weeks in a double-blind, placebo-controlled, randomized clinical trial. Safety and efficacy outcome measures include: gastrointestinal symptoms/tolerance, hepatic panel, serum creatinine, weight, body composition, diet intake, hunger/fullness, lipid profile, blood glucose, and C-reactive protein. Examination of the safety and efficacy of glucomannan for achieving weight loss will extend our understanding of additional treatments that may be effective in combating a significant public health problem.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glucomannan	Two 665 mg capsules of glucomannan three times a day for 8 weeks
DIETARY_SUPPLEMENT	Inert microcrystalline cellulose	Two capsules of inert microcrystalline cellulose three times a day for eight weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-02-13
• Last updated: 2011-12-02

Locations

1 site across 1 country: United States