Clinical Trials Directory

Trials / Completed

CompletedNCT01051674

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
173 (actual)
Sponsor
Loma Linda University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERHigh fiber vs. low-carbohydrate dietsHigh 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.

Timeline

Start date
2010-01-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2010-01-18
Last updated
2014-07-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01051674. Inclusion in this directory is not an endorsement.