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

NCT00498394 | Completed Phase 1

• 1 other identifier: 0060334B
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Weight loss; Diet fads

Outcome Measures

Primary Outcomes (1)

• Body weight

  6 months

Secondary Outcomes (6)

• Body fat via dual energy x-ray absorptiometry (DXA)

  6 months

• Resting metabolic rate via indirect calorimetry

  6 months

• Blood pressure

  6 months

• Fasting plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides

  6 months

• Fasting insulin and glucose

  6 months

Interventions

Clinical diet trial BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead
• American Heart Association: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221-0038, United States

Location

Related Publications (3)

• 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.

  PMID: 12679447 RESULT

• 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.

  PMID: 15598683 RESULT

• 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.

  PMID: 15671108 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Bonnie J Brehm, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 10, 2007
• Study Start: June 1, 2000
• Study Completion: October 1, 2002
• Last Updated: July 10, 2007

Record last verified: 2007-07

Locations

US (1)