A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss - Full Text View

Sponsor:	Loma Linda University
Collaborator:	Lifestyle Center of America
Information provided by:	Loma Linda University
ClinicalTrials.gov Identifier:	NCT01051674

Purpose

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.

Condition	Intervention	Phase
Obesity Type 2 Diabetes	Other: High fiber vs. low-carbohydrate diets	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Dietary Fiber Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lipid profiles [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Gastrointestinal hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
C-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Blood glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Serum insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	173
Study Start Date:	January 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High fiber diet	Other: High fiber vs. low-carbohydrate diets 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.
Experimental: Low-carbohydrate diet	Other: High fiber vs. low-carbohydrate diets 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051674

Locations

United States, California
Loma Linda U Medical Center Diabetes Treatment Center
Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Lifestyle Center of America

Investigators

Study Chair:

Serena Tonstad, MD, PhD, MPH

Loma Linda University

More Information

No publications provided

Responsible Party:	Serena Tonstad, MD, PhD, MPH, Loma Linda U School of Public Health, Department of Health Promotion & Education
ClinicalTrials.gov Identifier:	NCT01051674 History of Changes
Other Study ID Numbers:	59217
Study First Received:	January 14, 2010
Last Updated:	May 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:

Obesity
Type 2 diabetes
Fiber

Dietary fiber
Low-carbohydrate diet
High protein diet

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on February 09, 2012