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

Completed · Phase 4

Conditions studied: Obesity, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01051674

Run by

Loma Linda University

People needed

173

Starts

2010-01-01

Expected to finish

2011-09-01

Last updated by the study team

2014-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI 30.0-42.0 kg/m2
• English-speaking

You may not qualify if…

• 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

Where it is running

• Loma Linda U Medical Center Diabetes Treatment Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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