Status:
COMPLETED
Safety and Effectiveness Study of a Fiber Supplement for Weight Loss
Lead Sponsor:
Rush University Medical Center
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00613600
Start Date
February 1 2008
End Date
July 1 2009
Last Update
December 2 2011
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612