Clinical trial NCT00079547: The Safety and Effectiveness of Low and High Carbohydrate Diets
Official title: The Safety and Efficacy of Low and High Carbohydrate Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Weight Loss
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2004-03-10
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: weight change
timeFrame: 2 years
Secondary outcomes:
measure: change in lipids
timeFrame: 2 years
measure: blood pressure change
timeFrame: 2 years
measure: Ketones
timeFrame: 2 years
measure: Endothelial Function
timeFrame: 2
measure: change in exercise endurance
timeFrame: 2 years
measure: change in renal function
timeFrame: 2 years
measure: change in bone density
timeFrame: 2 years
measure: change in body composition
timeFrame: 2 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Gary D Foster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Holly Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: James Hill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de las Fuentes L, Waggoner AD, Mohammed BS, Stein RI, Miller BV 3rd, Foster GD, Wyatt HR, Klein S, Davila-Roman VG. Effect of moderate diet-induced weight loss and weight regain on cardiovascular structure and function. J Am Coll Cardiol. 2009 Dec 15;54(25):2376-81. doi: 10.1016/j.jacc.2009.07.054.