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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00498394
First received: July 6, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention Phase
Obesity
Behavioral: Clinical diet trial
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

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

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

Enrollment: 103
Study Start Date: June 2000
Study Completion Date: October 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498394

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221-0038
Sponsors and Collaborators
University of Cincinnati
American Heart Association
Investigators
Principal Investigator: Bonnie J Brehm, PhD University of Cincinnati