The Safety and Effectiveness of Low and High Carbohydrate Diets

Temple University

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Behavioral: Low-calorie diet; Behavioral: low-carbohydrate diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00079547

R01AT001103-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 307 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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307 participants in 2 patient groups

1

Active Comparator group

Description:

Low-calorie diet

Treatment:

Behavioral: Low-calorie diet

2

Experimental group

Description:

Low-carbohydrate diet

Treatment:

Behavioral: low-carbohydrate diet