Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00613600

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Dietary Supplement: Glucomannan Dietary Supplement: Inert microcrystalline cellulose	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Glucomannan for Weight Loss

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Two 665 mg capsules of glucomannan three times a day for eight weeks	Dietary Supplement: Glucomannan Two 665 mg capsules of glucomannan three times a day for 8 weeks
Placebo Comparator: 2 Two capsules of inert microcrystalline cellulose three times a day for eight weeks	Dietary Supplement: Inert microcrystalline cellulose Two capsules of inert microcrystalline cellulose three times a day for eight weeks

Arm

Intervention/Treatment

Experimental: 1

Two 665 mg capsules of glucomannan three times a day for eight weeks

Dietary Supplement: Glucomannan

Two 665 mg capsules of glucomannan three times a day for 8 weeks

Placebo Comparator: 2

Two capsules of inert microcrystalline cellulose three times a day for eight weeks

Dietary Supplement: Inert microcrystalline cellulose

Two capsules of inert microcrystalline cellulose three times a day for eight weeks

Outcome Measures

Primary Outcome Measures

Weight loss [8 weeks]

Secondary Outcome Measures

Body composition [8 weeks]
Dietary intake [8 weeks]
Hunger and fullness [8 weeks]
Lipid profile [8 weeks]
Fasting blood glucose [8 weeks]
C-reactive protein [8 weeks]
Gastrointestinal symptoms and tolerance [8 weeks]
Hepatic panel [8 weeks]
Serum creatinine [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > or = 18 and < or = 65 years
body mass index (BMI) > or = 25 and < or = 35 at study entry
speak and understand English (since translated versions of study tools have not been validated)
for females only: without childbearing potential or negative HCG hormone blood test and use of an appropriate form of contraception
signed informed consent form and HIPAA research authorization

Exclusion Criteria:

current use of fiber supplements or intolerance to fiber supplements
untreated/unstable metabolic conditions known to influence weight status (e.g., hypothyroidism, type 2 diabetes mellitus)
gastrointestinal disorders that might cause complications or influence motility or satiety (e.g., diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
Stage II hypertension (> or = 160/100 mg Hg) or dyslipidemia (fasting LDL cholesterol

or = 160 mg/dL; total cholesterol > or = 240 mg/dL; triglycerides > 200 mg/dL; HDL < or = 40 mg/dL)

fasting serum glucose > 126 mg/dL
acute or unstable cardiovascular, pulmonary, hepatic, renal, or psychiatric disorders
conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
use of medications that might affect weight or food absorption (e.g., diuretics, glucocorticoids, anorexigenic agents, Orlistat, laxatives)
use of CAM therapies that might affect weight (e.g., acupuncture, Hoodia)
weight change of > 5% body weight within 3 months of entry into the study
active eating disorders or active participation in a weight loss program
renal function impairment as evidenced by a history of renal disease or a serum creatinine > 2.0 mg/dL
liver function impairment as evidenced by a history of liver disease or liver enzyme elevations > three times the upper limit of normal (i.e., ALT > 150 u/L and/or AST > 165 u/L)
evidence of depression as determined by a weighted score of > or = 16 on the Center for Epidemiological Studies Depression Scale (CES-D), as this may affect eating behavior and adherence to the study protocol
currently consumes > or = 10 alcoholic drinks/week, as determined by self-report
currently smokes cigarettes due to the effects of nicotine on appetite and C-reactive protein levels
use of illicit drugs currently or in the last six months, as determined by self-report
for females only: pregnant, less than 6 months postpartum or 6 months post-termination of pregnancy, or currently lactating, due to lack of safety data in this population