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Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Glucomannan

Inert microcrystalline cellulose

About this trial

This is an interventional treatment trial for Overweight focused on measuring Safety, Efficacy, Glucomannan, Dietary fiber, Weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Body composition

Dietary intake

Hunger and fullness

Lipid profile

Fasting blood glucose

C-reactive protein

Gastrointestinal symptoms and tolerance

Hepatic panel

Serum creatinine

Full Information

NCT ID

NCT00613600

First Posted

January 31, 2008

Last Updated

December 1, 2011

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00613600

Brief Title

Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

Official Title

Safety and Efficacy of Glucomannan for Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

Safety, Efficacy, Glucomannan, Dietary fiber, Weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Glucomannan

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Inert microcrystalline cellulose

Intervention Description

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

Primary Outcome Measure Information:

Title

Weight loss

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Body composition

Time Frame

8 weeks

Title

Dietary intake

Time Frame

8 weeks

Title

Hunger and fullness

Time Frame

8 weeks

Title

Lipid profile

Time Frame

8 weeks

Title

Fasting blood glucose

Time Frame

8 weeks

Title

C-reactive protein

Time Frame

8 weeks

Title

Gastrointestinal symptoms and tolerance

Time Frame

8 weeks

Title

Hepatic panel

Time Frame

8 weeks

Title

Serum creatinine

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joyce K Keithley, DNSc, RN

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24490058

Citation

Keithley JK, Swanson B, Mikolaitis SL, DeMeo M, Zeller JM, Fogg L, Adamji J. Safety and efficacy of glucomannan for weight loss in overweight and moderately obese adults. J Obes. 2013;2013:610908. doi: 10.1155/2013/610908. Epub 2013 Dec 30.

Results Reference

derived

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Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

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