The Safety and Efficacy of Low and High Carbohydrate Diets

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00143936
First received: September 1, 2005
Last updated: January 14, 2010
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Obesity
Behavioral: Low- Carbohydrate -Atkins Diet
Behavioral: Low Calorie Diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Low and High Carbohydrate Diets

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: April 2003
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Carb
Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish
Behavioral: Low- Carbohydrate -Atkins Diet
Low Carbohydrate Diet
Other Name: low carb
Active Comparator: Low Calorie
Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years
Behavioral: Low Calorie Diet
Maintain a low calorie diet
Other Name: low cal

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143936

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Gary Foster, PhD University of Pennsylvania
Principal Investigator: Holly Wyatt, MD University of Colorado, Denver
Principal Investigator: James Hill, PhD University of Colorado, Denver
Principal Investigator: Samuel Klein, MD Washington University
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary D. Foster, PhD, Temple University
ClinicalTrials.gov Identifier: NCT00143936     History of Changes
Other Study ID Numbers: R01 AT 001103, 1 R01 AT01103-01
Study First Received: September 1, 2005
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Weight Loss

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014