- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00498394
Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors
July 6, 2007 updated by: University of Cincinnati
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45221-0038
- University of Cincinnati
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 6 months
|
6 months
|
Body fat via dual energy x-ray absorptiometry (DXA)
Time Frame: 6 months
|
6 months
|
Resting metabolic rate via indirect calorimetry
Time Frame: 6 months
|
6 months
|
Fasting plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides
Time Frame: 6 months
|
6 months
|
Fasting insulin and glucose
Time Frame: 6 months
|
6 months
|
Psychological health and eating behaviors via surveys
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bonnie J Brehm, PhD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. doi: 10.1210/jc.2002-021480.
- Brehm BJ, Spang SE, Lattin BL, Seeley RJ, Daniels SR, D'Alessio DA. The role of energy expenditure in the differential weight loss in obese women on low-fat and low-carbohydrate diets. J Clin Endocrinol Metab. 2005 Mar;90(3):1475-82. doi: 10.1210/jc.2004-1540. Epub 2004 Dec 14.
- O'Brien KD, Brehm BJ, Seeley RJ, Bean J, Wener MH, Daniels S, D'Alessio DA. Diet-induced weight loss is associated with decreases in plasma serum amyloid a and C-reactive protein independent of dietary macronutrient composition in obese subjects. J Clin Endocrinol Metab. 2005 Apr;90(4):2244-9. doi: 10.1210/jc.2004-1011. Epub 2005 Jan 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Study Completion (Actual)
October 1, 2002
Study Registration Dates
First Submitted
July 6, 2007
First Submitted That Met QC Criteria
July 6, 2007
First Posted (Estimate)
July 10, 2007
Study Record Updates
Last Update Posted (Estimate)
July 10, 2007
Last Update Submitted That Met QC Criteria
July 6, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0060334B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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