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

NCT01051674 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2014-07-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lifestyle Center of America

    collaborator OTHER

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Serena Tonstad, MD, PhD, MPH · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051674 on ClinicalTrials.gov