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

NCT ID: NCT01051674

Last Updated: 2014-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High fiber diet

Group Type EXPERIMENTAL

High fiber vs. low-carbohydrate diets

Intervention Type OTHER

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.

Low-carbohydrate diet

Group Type EXPERIMENTAL

High fiber vs. low-carbohydrate diets

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lifestyle Center of America

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Serena Tonstad, MD, PhD, MPH

Role: STUDY_CHAIR

Loma Linda University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda U Medical Center Diabetes Treatment Center

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

59217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Fiber on Satiety
NCT01588600 COMPLETED NA
The Energy Balance Study
NCT01029483 COMPLETED PHASE1
Energy Balance Weight Regulation Study
NCT00619008 COMPLETED PHASE2
The Personalized Nutrition Study
NCT04145466 COMPLETED NA