Safety and Effectiveness Study of a Fiber Supplement for Weight Loss

Completed · Phase 2

Conditions studied: Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT00613600

Run by

Rush University Medical Center

People needed

50

Starts

2008-02-01

Expected to finish

2009-07-01

Last updated by the study team

2011-12-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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