Clinical trial NCT00682916: Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol
Official title: CCRC: FBCx® And Body Weight Regulation in Overweight Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Diabetes
Soluble Fiber
Overweight
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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.

Primary outcomes:
measure: without any altering of dietary habits or exercise routine, individuals shall lose or maintain body weight during the active phase as compared to the placebo phase.
timeFrame: 4 weeks
Secondary outcomes:
measure: blood lipid levels during the active phase will be improved relative to the placebo phase.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: UC Davis
name: Sidika E Kasim-Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References: