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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jens Jordan, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00956566
First received: August 10, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 Hannover Medical School:

Primary Outcome Measures:
  • Body weight reduction [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight maintenance [ Time Frame: Month 12 - 36 ] [ Designated as safety issue: No ]
    follow up assesement after 6 months diet

  • Reduction of visceral adipose tissue mass [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Reduction of left ventricular mass [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Influence on energy expenditure and fat oxidation rates [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Hannover Medical School

Additional 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
Study First Received: August 10, 2009
Last Updated: July 27, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014