Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects (B-SMART)

Hannover Medical School (MHH)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00956566

B-SMART

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

low fat hypocaloric diet

Active Comparator group

Treatment:

Behavioral: dietary intervention

Low carbohydrate hypocaloric diet

Active Comparator group

Treatment:

Behavioral: dietary intervention