A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
Primary Purpose
Obesity, Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
High fiber vs. low-carbohydrate diets
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Type 2 diabetes, Fiber, Dietary fiber, Low-carbohydrate diet, High protein diet
Eligibility Criteria
Inclusion Criteria:
- BMI 30.0-42.0 kg/m2
- English-speaking
Exclusion Criteria:
- Pregnancy
- Lactation
- Acute or chronic infection
- Type 1 diabetes
- Participation in another trial
- Active cancers
- Currently using Byetta
- Currently on weight loss medication
- Weight loss of more than 4 lbs. within the last 3 months
- Vegan
- Active eating disorder
- Gastrointestinal problems that may be worsened by a high fiber intake
Sites / Locations
- Loma Linda U Medical Center Diabetes Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High fiber diet
Low-carbohydrate diet
Arm Description
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Lipid profiles
Gastrointestinal hormones
Waist circumference
C-reactive protein
Blood glucose
Serum insulin
Hemoglobin A1c
Full Information
NCT ID
NCT01051674
First Posted
January 14, 2010
Last Updated
June 27, 2014
Sponsor
Loma Linda University
Collaborators
Lifestyle Center of America
1. Study Identification
Unique Protocol Identification Number
NCT01051674
Brief Title
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
Official Title
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Lifestyle Center of America
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Type 2 diabetes, Fiber, Dietary fiber, Low-carbohydrate diet, High protein diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fiber diet
Arm Type
Experimental
Arm Title
Low-carbohydrate diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High fiber vs. low-carbohydrate diets
Intervention Description
High fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women.
Primary Outcome Measure Information:
Title
Weight
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Lipid profiles
Time Frame
1 year
Title
Gastrointestinal hormones
Time Frame
1 year
Title
Waist circumference
Time Frame
1 year
Title
C-reactive protein
Time Frame
1 year
Title
Blood glucose
Time Frame
1 year
Title
Serum insulin
Time Frame
1 year
Title
Hemoglobin A1c
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI 30.0-42.0 kg/m2
English-speaking
Exclusion Criteria:
Pregnancy
Lactation
Acute or chronic infection
Type 1 diabetes
Participation in another trial
Active cancers
Currently using Byetta
Currently on weight loss medication
Weight loss of more than 4 lbs. within the last 3 months
Vegan
Active eating disorder
Gastrointestinal problems that may be worsened by a high fiber intake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena Tonstad, MD, PhD, MPH
Organizational Affiliation
Loma Linda University
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda U Medical Center Diabetes Treatment Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
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A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
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