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

Obesity Clinical Trial

Official title:

A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051674
• Other study ID #: 59217
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2010
• Last updated: June 27, 2014
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda U Medical Center Diabetes Treatment Center	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Lifestyle Center of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		1 year	No
Secondary	Lipid profiles		1 year	No
Secondary	Gastrointestinal hormones		1 year	No
Secondary	Waist circumference		1 year	No
Secondary	C-reactive protein		1 year	No
Secondary	Blood glucose		1 year	No
Secondary	Serum insulin		1 year	No
Secondary	Hemoglobin A1c		1 year	No