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

This study has been completed.
Information provided by (Responsible Party):
Prof. Dr. Jens Jordan, Hannover Medical School Identifier:
First received: August 10, 2009
Last updated: July 27, 2012
Last verified: July 2012
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.

Condition Intervention
Obesity Behavioral: dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.

Resource links provided by NLM:

Further study details as provided by Prof. Dr. Jens Jordan, Hannover Medical School:

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

Secondary Outcome Measures:
  • Weight maintenance [ Time Frame: Month 12 - 36 ]
    follow up assesement after 6 months diet

  • Reduction of visceral adipose tissue mass [ Time Frame: Month 6 ]
  • Reduction of left ventricular mass [ Time Frame: Month 6 ]
  • Influence on energy expenditure and fat oxidation rates [ Time Frame: Month 6 ]

Enrollment: 170
Study Start Date: April 2007
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low fat hypocaloric diet Behavioral: dietary intervention
dietary counseling, group teaching
Active Comparator: Low carbohydrate hypocaloric diet Behavioral: dietary intervention
dietary counseling, group teaching


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00956566

Experimental & Clinical Research Center
Berlin, Germany, 13125
Sponsors and Collaborators
Hannover Medical School
Principal Investigator: Jens Jordan, MD Hannover Medical School
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Prof. Dr. Jens Jordan, Prof. Dr. med., Hannover Medical School Identifier: NCT00956566     History of Changes
Other Study ID Numbers: B-SMART
Study First Received: August 10, 2009
Last Updated: July 27, 2012 processed this record on June 23, 2017