Status:
COMPLETED
Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol
Lead Sponsor:
University of California, Davis
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in much of the developed world. Historically several different dietary fibers have been used as means of reduc...
Detailed Description
The overall aim is to investigate the effectiveness of a soluble dietary fiber, FBCx®, on weight loss and/or weight management, and blood lipid levels in overweight humans.
Eligibility Criteria
Inclusion
- 30 men and 30 women
- Age 18- 65 years
- BMI 25.0 - 32.0 Kg/m²
- fasting glucose \<126 mg/dL
- Blood pressure \< 140/85 mm Hg. Hypertension on stable drug regimen using 2 or fewer antihypertensives will be acceptable.
- Total plasma cholesterol \<240 mg/dl, LDL-cholesterol \<160 and triglycerides \<400 mg/dl. Hyperlipidemia on a stable medication regimen using single anti-hyperlipidemic drug acceptable.
Exclusion
- Pregnant women, women who plan to become pregnant during the study period
- Women who have given birth within the previous 12 months
- Lactating women
- History or presence of Type 2 diabetes; kidney disease; (creatinine \>1.4); liver disease (X2 fold increase in AST or ALT); gout; cancer; untreated thyroid disease; gastrointestinal disease; other metabolic diseases or malabsorption syndromes
- Habitual low-fat intake (less than 20%)
- History of eating disorder
- Subjects who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program
- Use of prescription or over-the counter anti-obesity medications or supplements (phenylpropanolamine, ephedrine, caffeine) for at least 6 months prior of study.
- Subjects with pacemakers will not participate in bioimpedance studies but will go through all the other testing.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00682916
Start Date
April 1 2007
End Date
December 1 2008
Last Update
May 30 2017
Active Locations (1)
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1
UC Davis
Sacramento, California, United States, 95817