Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | April 2007 |
| End Date: | July 2008 |
| Contact: | Melinda Posas, BS |
| Email: | velayo.melinda@gmail.com |
| Phone: | 916-734-4747 |
CCRC: FBCx® And Body Weight Regulation in Overweight Humans
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 reducing body weight and the related development of type 2 diabetes. These
studies have generated mixed, if not inconsistent, results suggesting that none of these
fibers promise a solution to either of these two conditions. We are proposing to
investigate the effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be
called Y288 in this study), into the diet of adult overweight volunteers.
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
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