Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol - Full Text View

Sponsor:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00682916

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:

MedlinePlus related topics: Cholesterol Dietary Fiber Dietary Supplements Obesity

U.S. FDA Resources

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 ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 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®

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682916

Contacts

Contact: Melinda Posas, BS	916-734-4747	velayo.melinda@gmail.com
Contact: Luisa M Vargas-Velazquez, CCRP	916-703-5480	maria.vargas@ucdmc.ucdavis.edu

Locations

United States, California
UC Davis	Recruiting
Sacramento, California, United States, 95817
Contact: Melinda Posas, BS 916-734-4777 velayo.melinda@gmail.com
Contact: Luisa M Vargas-Velazquez, CCRP 916-703-5480 maria.vargas@ucdmc.ucdavis.edu

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Sidika E Kasim-Karakas, MD

UC Davis

More Information

No publications provided

Responsible Party:	Sidika Kasim-Karakas, M.D., UC Davis
ClinicalTrials.gov Identifier:	NCT00682916 History of Changes
Other Study ID Numbers:	200715061-2
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
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 February 09, 2012