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

Phase 4

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Other: High fiber vs. low-carbohydrate diets

• Registration Number: NCT01051674
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High fiber diet	High fiber vs. low-carbohydrate diets	-
Low-carbohydrate diet	High fiber vs. low-carbohydrate diets	-

Primary Outcome Measures

Name	Time	Method
Weight	1 year

Secondary Outcome Measures

Name	Time	Method
Lipid profiles	1 year
Gastrointestinal hormones	1 year
Waist circumference	1 year
C-reactive protein	1 year
Blood glucose	1 year
Serum insulin	1 year
Hemoglobin A1c	1 year

Trial Locations

Locations (1)

Loma Linda U Medical Center Diabetes Treatment Center; 🇺🇸 Loma Linda, California, United States