Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidika E. Karakas, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00682916
First received: May 21, 2008
Last updated: October 25, 2012
Last verified: May 2008
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Y288

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: CCRC: FBCx® And Body Weight Regulation in Overweight Humans

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood lipid levels during the active phase will be improved relative to the placebo phase. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Subjects will fast prior to the initial visit. Subjects' weight, blood pressure and heart rate will be recorded, waist and hip circumferences measured, and body composition determined. They will receive either the soluble fiber or placebo tablets, in a coded bottle. They will be instructed to take 2 tablets per fat containing meal, 3 times a day within one hour of consuming the meal. They will also be asked to keep records of missed doses and any gastrointestinal symptoms (e.g.: heartburn, indigestion, diarrhea, constipation). During the 4th week, they will be asked to record food intakes for 3 days.

After taking the supplement for 4 weeks, the participants will return to the clinic after an overnight fast. During this visit, they will turn in their 3-day dietary record. The studies performed during the initial baseline visit will be repeated. At this visit they receive the alternate supplement (placebo or active tablets) in a identical-looking coded bottle.

Dietary Supplement: Y288
Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
Other Name: FBCx®
Placebo Comparator: 2

Subjects will fast prior to the initial visit. Subjects' weight, blood pressure and heart rate will be recorded, waist and hip circumferences measured, and body composition determined. They will receive either the soluble fiber or placebo tablets, in a coded bottle. They will be instructed to take 2 tablets per fat containing meal, 3 times a day within one hour of consuming the meal. They will also be asked to keep records of missed doses and any gastrointestinal symptoms (e.g.: heartburn, indigestion, diarrhea, constipation). During the 4th week, they will be asked to record food intakes for 3 days.

After taking the supplement for 4 weeks, the participants will return to the clinic after an overnight fast. During this visit, they will turn in their 3-day dietary record. The studies performed during the initial baseline visit will be repeated. At this visit they receive the alternate supplement (placebo or active tablets) in a identical-looking coded bottle.

Dietary Supplement: Y288
Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
Other Name: FBCx®

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00682916

Locations
United States, California
UC Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Sidika E. Karakas, MD
Investigators
Principal Investigator: Sidika E Kasim-Karakas, MD UC Davis
  More Information

No publications provided

Responsible Party: Sidika E. Karakas, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00682916     History of Changes
Other Study ID Numbers: 200715061-2
Study First Received: May 21, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Obesity
Diabetes
Soluble Fiber
Overweight

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014