Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

NCT00613600 | Completed Phase 2 DMC

• 1 other identifier: RTF-GM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Safety; Efficacy; Glucomannan; Dietary fiber; Weight loss

Outcome Measures

Primary Outcomes (1)

• Weight loss

  8 weeks

Secondary Outcomes (9)

• Body composition

  8 weeks

• Dietary intake

  8 weeks

• Hunger and fullness

  8 weeks

• Lipid profile

  8 weeks

• Fasting blood glucose

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Glucomannan

2

PLACEBO COMPARATOR

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

Dietary Supplement: Inert microcrystalline cellulose

Interventions

Glucomannan DIETARY_SUPPLEMENT

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

1

Inert microcrystalline cellulose DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 24490058 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

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

Study Officials

• Joyce K Keithley, DNSc, RN

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 2, 2011

Record last verified: 2011-12

Locations

US (1)