Completed

The Safety and Efficacy of Low and High Carbohydrate Diets

What is being tested

Low-calorie diet

+ low-carbohydrate diet

Behavioral

Who is being recruted

Body Weight+7

+ Body Weight Changes

+ Nutrition Disorders

From 18 to 65 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: April 2003

See protocol details

Summary

Principal SponsorTemple University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2003

Actual date on which the first participant was enrolled.

Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women. Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low-fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition; 2) metabolic and organ function; and 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.

Official TitleThe Safety and Efficacy of Low and High Carbohydrate Diets

NCT00079547

Principal SponsorTemple University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

307 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossOvernutritionOverweight

Criteria

3 inclusion criteria required to participate

Body mass index between 30 and 40

Live and work within 1 hour of the study site

Stable psychological status

15 exclusion criteria prevent from participating

Osteoporosis

History of heart disease, heart attack, or stroke

Blood pressure >140/90 mmHg

Abnormal cholesterol levels

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Low-calorie diet

Group II

Experimental

Low-carbohydrate diet

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of Colorado

Denver, United StatesOpen University of Colorado in Google Maps

Suspended

Washington University

St Louis, United States

Suspended

University of Pennsylvania

Philadelphia, United States

Completed3 Study Centers