The Safety and Effectiveness of Low and High Carbohydrate Diets

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

Official Title

The Safety and Efficacy of Low and High Carbohydrate Diets

Conditions

– Obesity

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further Details

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 Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 65 Years, Genders Eligible for Study: Both Accepts Healthy VolunteersCriteria Inclusion CriteriaBody mass index between 30 and 40 Live and work within 1 hour of the study site Stable psychological status Exclusion criteriaHistory 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

Total Enrolment

360

Contact Details

[1] Gary D Foster, PhD, Principal Investigator, University of Pennsylvania [2] Holly Wyatt, MD, Principal Investigator, University of Colorado [3] James Hill, PhD, Principal Investigator, University of Colorado [4] Samuel Klein, MD, Principal Investigator, Washington University School of Medicine