The Safety and Effectiveness of Low and High Carbohydrate Diets

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00079547
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), Office of Dietary Supplements (ODS) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 307
• Locations: 3
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 102.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Low-calorie diet; Behavioral: low-carbohydrate diet	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of Low and High Carbohydrate Diets
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Low-calorie diet	Behavioral: Low-calorie diet; low-calorie diet
Experimental: 2 Low-carbohydrate diet	Behavioral: low-carbohydrate diet; low-carbohydrate diet

Outcome Measures

Primary Outcome Measures

1. weight change [2 years]

Secondary Outcome Measures

1. change in lipids [2 years]

2. blood pressure change [2 years]

3. Ketones [2 years]

4. Endothelial Function [2]

5. change in exercise endurance [2 years]

6. change in renal function [2 years]

7. change in bone density [2 years]

8. change in body composition [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Body mass index between 30 and 40

• Live and work within 1 hour of the study site

• Stable psychological status

Exclusion criteria

• History of heart disease, heart attack, or stroke

• Blood pressure >140/90 mmHg

• Abnormal cholesterol levels

• Significant psychiatric illness

• Any medication that affects weight or metabolic rate

• Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)

• Currently using antidepressants, steroids, tobacco, or illegal drugs

• Pregnant, breastfeeding, or planning pregnancy

• 10 lb change in weight within 6 months of study entry

• History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease

• History of protein wasting diseases or gout

• Severe arthritis

• Osteoporosis

• Certain types of hormone replacement therapy

• Currently following a vegetarian diet

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Denver	Colorado	United States	80262
2	Washington University	St. Louis	Missouri	United States	63110
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Temple University
• National Center for Complementary and Integrative Health (NCCIH)
• Office of Dietary Supplements (ODS)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Gary D Foster, PhD, University of Pennsylvania
• Principal Investigator: Holly Wyatt, MD, University of Colorado, Denver
• Principal Investigator: James Hill, PhD, University of Colorado, Denver
• Principal Investigator: Samuel Klein, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT00079547
• Other Study ID Numbers: R01AT001103-01; R01AT001103-01
• First Posted: Mar 10, 2004
• Last Update Posted: Jul 1, 2013
• Last Verified: Jan 1, 2008

• Keywords provided by Temple University: Weight Loss

Study Results

No Results Posted as of Jul 1, 2013