Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: dietary intervention

• Registration Number: NCT00956566
• Lead Sponsor: Hannover Medical School

Brief Summary

The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2011-12
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Body Mass Index > 27 kg/m2
• No chronic medication (except oral contraceptives and L-Thyroxine) or possibility to stop medication for study duration
• Able to give written informed consent

Exclusion Criteria

• Pregnancy and nursing
• Severe cardiovascular, liver, kidney, hepatic or orthopedic disease that need treatment
• Metabolic or endocrine disease that need treatment
• Hypertension blood pressure > 160/95 mmHg or need of > 2 drugs
• Previous stroke or cerebral ischemia
• Significant neurologic or psychiatric disease
• Any kind of eating disorder
• Bariatric surgery in the past
• Drug or alcohol abuse
• Any cancer in the past
• Acute and chronic infections
• Metallic implants (e.g. pace makers) or conditions that do not allow MRI scans
• Body weight > 130 kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low fat hypocaloric diet	dietary intervention	-
Low carbohydrate hypocaloric diet	dietary intervention	-

Primary Outcome Measures

Name	Time	Method
Body weight reduction	Month 6

Secondary Outcome Measures

Name	Time	Method
Reduction of left ventricular mass	Month 6
Influence on energy expenditure and fat oxidation rates	Month 6
Weight maintenance	Month 12 - 36	follow up assesement after 6 months diet
Reduction of visceral adipose tissue mass	Month 6

Trial Locations

Locations (1)

Experimental & Clinical Research Center; 🇩🇪 Berlin, Germany