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

History of Changes

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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):

Haufe S, Utz W, Engeli S, Kast P, Böhnke J, Pofahl M, Traber J, Haas V, Hermsdorf M, Mähler A, Busjahn A, Wiesner S, Otto C, Mehling H, Luft FC, Boschmann M, Schulz-Menger J, Jordan J. Left ventricular mass and function with reduced-fat or reduced-carbohydrate hypocaloric diets in overweight and obese subjects. Hypertension. 2012 Jan;59(1):70-5. Epub 2011 Nov 7.

Utz W, Engeli S, Haufe S, Kast P, Hermsdorf M, Wiesner S, Pofahl M, Traber J, Luft FC, Boschmann M, Schulz-Menger J, Jordan J. Myocardial steatosis, cardiac remodelling and fitness in insulin-sensitive and insulin-resistant obese women. Heart. 2011 Oct;97(19):1585-9. Epub 2011 Jul 20.

Haufe S, Engeli S, Kast P, Böhnke J, Utz W, Haas V, Hermsdorf M, Mähler A, Wiesner S, Birkenfeld AL, Sell H, Otto C, Mehling H, Luft FC, Eckel J, Schulz-Menger J, Boschmann M, Jordan J. Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects. Hepatology. 2011 May;53(5):1504-14. Epub 2011 Mar 11.

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 June 18, 2013

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