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Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT00498394
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
American Heart Association
Information provided by:
University of Cincinnati

Brief Summary:
This pilot study is a randomized, controlled clinical trial to compare anthropometric and metabolic changes associated with six months of weight management by means of a very low carbohydrate diet or a calorically-restricted low fat diet. We hypothesized that the low fat diet would be associated with more weight loss and improvement of cardiovascular risk factors than the low carbohydrate diet.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Clinical diet trial Phase 1

Detailed Description:
Low carbohydrate diets, including high-fat, 'ketogenic' diets, have moved to the forefront of popular diets promoted for weight loss in the United States. These diet plans have been aggressively marketed to millions of Americans every year. However, there has been virtually no rigorous study of low carbohydrate, high fat diets either with regard to efficacy in promoting weight loss or effects on cardiovascular risk factors. Because very low carbohydrate diets (i.e., the ketogenic diets) recommend increased intake of fat, and saturated fat, we hypothesized that following one of these diet plans could actually worsen important risk factors for cardiovascular disease. This is an issue of great importance because large numbers of people experiment with low carbohydrate diets despite not knowing their effects on blood pressure, plasma lipid levels, and glucose tolerance. Therefore, we have proposed a clinical trial to test our hypothesis. In this study, we will compare the effects of three months of a ketogenic diet (as promoted by Dr. Robert Atkins) with three months of a weight loss diet that conforms to the American Heart Association dietary guidelines in a group of 100 otherwise healthy obese subjects. During the course of the study, we will determine the effects of diet on 1) body weight, percent fat, and resting metabolic rate, 2) blood pressure, 3) plasma lipids, 4) measures of glucose tolerance, and 5) measures of psychological health and eating behaviors. This pilot study will provide the preliminary data needed to demonstrate the efficacy (or lack thereof) of a popular weight loss technique (i.e., the ketogenic diet) that is currently being criticized by professional organizations. Armed with preliminary data, the investigators plan to further investigate the long-term anthropometric and metabolic effects of ketogenic diets with a larger sample.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors
Study Start Date : June 2000
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Primary Outcome Measures :
  1. Body weight [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Body fat via dual energy x-ray absorptiometry (DXA) [ Time Frame: 6 months ]
  2. Resting metabolic rate via indirect calorimetry [ Time Frame: 6 months ]
  3. Blood pressure [ Time Frame: 6 months ]
  4. Fasting plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides [ Time Frame: 6 months ]
  5. Fasting insulin and glucose [ Time Frame: 6 months ]
  6. Psychological health and eating behaviors via surveys [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obese men and women with a BMI of 30-34 kg/m2, at least 18 years of age, who have had stable body weight (i.e., no gain or loss of >5% of body weight) for the preceding six months, who have normal oral glucose tolerance, and who are able to commit to a six month study.

Exclusion Criteria:

  • Pregnancy, lactation, active medical or mental illness requiring treatment, recent (within 1 year) use of appetite suppressing compounds, previous use of the ketogenic diet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498394

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221-0038
Sponsors and Collaborators
University of Cincinnati
American Heart Association
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Principal Investigator: Bonnie J Brehm, PhD University of Cincinnati
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00498394    
Other Study ID Numbers: 0060334B
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: July 2007
Keywords provided by University of Cincinnati:
Weight loss
Diet fads
Additional relevant MeSH terms:
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Body Weight