Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects

NCT00956566 | Completed

• 1 other identifier: B-SMART
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight reduction

  Month 6

Secondary Outcomes (4)

• Weight maintenance

  Month 12 - 36

• Reduction of visceral adipose tissue mass

  Month 6

• Reduction of left ventricular mass

  Month 6

• Influence on energy expenditure and fat oxidation rates

  Month 6

Study Arms (2)

low fat hypocaloric diet

ACTIVE COMPARATOR

Behavioral: dietary intervention

Low carbohydrate hypocaloric diet

ACTIVE COMPARATOR

Behavioral: dietary intervention

Interventions

dietary intervention BEHAVIORAL

dietary counseling, group teaching

Low carbohydrate hypocaloric diet; low fat hypocaloric diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (7)

• Haufe S, Engeli S, Kaminski J, Witt H, Rein D, Kamlage B, Utz W, Fuhrmann JC, Haas V, Mahler A, Schulz-Menger J, Luft FC, Boschmann M, Jordan J. Branched-chain amino acid catabolism rather than amino acids plasma concentrations is associated with diet-induced changes in insulin resistance in overweight to obese individuals. Nutr Metab Cardiovasc Dis. 2017 Oct;27(10):858-864. doi: 10.1016/j.numecd.2017.07.001. Epub 2017 Jul 11.

  PMID: 28958691 DERIVED

• Haufe S, Haas V, Utz W, Birkenfeld AL, Jeran S, Bohnke J, Mahler A, Luft FC, Schulz-Menger J, Boschmann M, Jordan J, Engeli S. Long-lasting improvements in liver fat and metabolism despite body weight regain after dietary weight loss. Diabetes Care. 2013 Nov;36(11):3786-92. doi: 10.2337/dc13-0102. Epub 2013 Aug 20.

  PMID: 23963894 DERIVED

• Engeli S, Utz W, Haufe S, Lamounier-Zepter V, Pofahl M, Traber J, Janke J, Luft FC, Boschmann M, Schulz-Menger J, Jordan J. Fatty acid binding protein 4 predicts left ventricular mass and longitudinal function in overweight and obese women. Heart. 2013 Jul;99(13):944-8. doi: 10.1136/heartjnl-2013-303735. Epub 2013 Apr 18.

  PMID: 23598540 DERIVED

• Utz W, Engeli S, Haufe S, Kast P, Bohnke J, Haas V, Hermsdorf M, Wiesner S, Pofahl M, Traber J, Luft FC, Boschmann M, Jordan J, Schulz-Menger J. Moderate dietary weight loss reduces myocardial steatosis in obese and overweight women. Int J Cardiol. 2013 Aug 10;167(3):905-9. doi: 10.1016/j.ijcard.2012.03.104. Epub 2012 Apr 10.

  PMID: 22494864 DERIVED

• Haufe S, Utz W, Engeli S, Kast P, Bohnke J, Pofahl M, Traber J, Haas V, Hermsdorf M, Mahler 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. doi: 10.1161/HYPERTENSIONAHA.111.178616. Epub 2011 Nov 7.

  PMID: 22068866 DERIVED

• 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. doi: 10.1136/hrt.2011.224451. Epub 2011 Jul 20.

  PMID: 21775510 DERIVED

• Haufe S, Engeli S, Kast P, Bohnke J, Utz W, Haas V, Hermsdorf M, Mahler 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. doi: 10.1002/hep.24242. Epub 2011 Mar 11.

  PMID: 21400557 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Jens Jordan, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: April 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

DE (1)