The Safety and Effectiveness of Low and High Carbohydrate Diets
NCT ID: NCT00079547
Last Updated: 2013-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
307 participants
INTERVENTIONAL
2003-04-30
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Low-calorie diet
Low-calorie diet
low-calorie diet
2
Low-carbohydrate diet
low-carbohydrate diet
low-carbohydrate diet
Interventions
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Low-calorie diet
low-calorie diet
low-carbohydrate diet
low-carbohydrate diet
Eligibility Criteria
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Inclusion Criteria
* Live and work within 1 hour of the study site
* Stable psychological status
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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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
Temple University
OTHER
Responsible Party
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Principal Investigators
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Gary D Foster, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Holly Wyatt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
James Hill, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Samuel Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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University of Colorado
Denver, Colorado, United States
Washington University
St Louis, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Other Identifiers
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