Clinical trial NCT00143936: The Safety and Efficacy 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: National Institutes of Health (NIH)
First posted: 2005-09-02
Enrollment: 360
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 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, 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 appettite, 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
* Osteoperosis
* Certain types of hormone replacement therapy
* Currently following a vegetarian diet

Primary outcomes:
measure: Weight loss
timeFrame: 2 years
Secondary outcomes:
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: Temple University
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Gary 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: Friedman AN, Ogden LG, Foster GD, Klein S, Stein R, Miller B, Hill JO, Brill C, Bailer B, Rosenbaum DR, Wyatt HR. Comparative effects of low-carbohydrate high-protein versus low-fat diets on the kidney. Clin J Am Soc Nephrol. 2012 Jul;7(7):1103-11. doi: 10.2215/CJN.11741111. Epub 2012 May 31.
citation: Borradaile KE, Halpern SD, Wyatt HR, Klein S, Hill JO, Bailer B, Brill C, Stein RI, Miller BV 3rd, Foster GD. Relationship between treatment preference and weight loss in the context of a randomized controlled trial. Obesity (Silver Spring). 2012 Jun;20(6):1218-22. doi: 10.1038/oby.2011.216. Epub 2011 Jul 14.
citation: Foster GD, Wyatt HR, Hill JO, Makris AP, Rosenbaum DL, Brill C, Stein RI, Mohammed BS, Miller B, Rader DJ, Zemel B, Wadden TA, Tenhave T, Newcomb CW, Klein S. Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Ann Intern Med. 2010 Aug 3;153(3):147-57. doi: 10.7326/0003-4819-153-3-201008030-00005.