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Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Y288
Y288
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Diabetes, Soluble Fiber, Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UC Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

blood lipid levels during the active phase will be improved relative to the placebo phase.

Full Information

First Posted
May 21, 2008
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00682916
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Diabetes, Soluble Fiber, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Y288
Other Intervention Name(s)
FBCx®
Intervention Description
Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Y288
Other Intervention Name(s)
FBCx®
Intervention Description
Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
blood lipid levels during the active phase will be improved relative to the placebo phase.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika E Kasim-Karakas, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol

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