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

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ClinicalTrials.gov Identifier: NCT00956566
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jens Jordan, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: dietary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956566


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

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

Responsible Party: Prof. Dr. Jens Jordan, Prof. Dr. med., Hannover Medical School
ClinicalTrials.gov Identifier: NCT00956566     History of Changes
Other Study ID Numbers: B-SMART
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012