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

Loma Linda University (LLU)

Status and phase: Completed; Phase 4

Conditions: Obesity; Type 2 Diabetes

Treatments: Other: High fiber vs. low-carbohydrate diets

Study type: Interventional

Funder types: Other

Identifiers

NCT01051674

59217

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

High fiber diet

Experimental group

Treatment:

Other: High fiber vs. low-carbohydrate diets

Low-carbohydrate diet

Experimental group

Treatment:

Other: High fiber vs. low-carbohydrate diets