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Completed

NCT Number: NCT00956566

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental & Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

dietary counseling, group teaching

Primary outcomes

  1. Body weight reduction

    Time frame: Month 6

Secondary outcomes

  1. Weight maintenance

    Time frame: Month 12 - 36

    follow up assesement after 6 months diet

  2. Reduction of visceral adipose tissue mass

    Time frame: Month 6

  3. Reduction of left ventricular mass

    Time frame: Month 6

  4. Influence on energy expenditure and fat oxidation rates

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study 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.

Acronym: B-SMART

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Aug 11, 2009
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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