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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 10, 2009
First Posted Date  ICMJE August 11, 2009
Last Update Posted Date July 30, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
Body weight reduction [ Time Frame: Month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
  • Weight maintenance [ Time Frame: Month 12 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: dietary intervention
dietary counseling, group teaching
Study Arms  ICMJE
  • Active Comparator: low fat hypocaloric diet
    Intervention: Behavioral: dietary intervention
  • Active Comparator: Low carbohydrate hypocaloric diet
    Intervention: Behavioral: dietary intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)
170
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2009)
190
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00956566
Other Study ID Numbers  ICMJE B-SMART
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. Dr. Jens Jordan, Hannover Medical School
Original Responsible Party Jens Jordan, MD, Professor of Clinical Pharmacology, Institute of Clinical Pharmacology
Current Study Sponsor  ICMJE Hannover Medical School
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens Jordan, MD Hannover Medical School
PRS Account Hannover Medical School
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP