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

NCT ID: NCT00956566

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low fat hypocaloric diet

Group Type ACTIVE_COMPARATOR

dietary intervention

Intervention Type BEHAVIORAL

dietary counseling, group teaching

Low carbohydrate hypocaloric diet

Group Type ACTIVE_COMPARATOR

dietary intervention

Intervention Type BEHAVIORAL

dietary counseling, group teaching

Interventions

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dietary intervention

dietary counseling, group teaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Jens Jordan

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Jordan, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Experimental & Clinical Research Center

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28958691 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23963894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23598540 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22494864 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22068866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21775510 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21400557 (View on PubMed)

Other Identifiers

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B-SMART

Identifier Type: -

Identifier Source: org_study_id