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OpenTrials
Completed

NCT Number: NCT00868387

Macronutrient Relations and Weight Loss in Obese Subjects

The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center North Rhine-Westfalia

Bad Oeynhausen, North Rhine-Westfalia, 32545, Germany

About this study

see brief summary.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 18-70 years
  • body mass index > 27 kg/m2

Exclusion criteria

  • history of cardiovascular symptomatology
  • cholelithiasis
  • urolithiasis
  • insulin dependent diabetes
  • pacemaker implantation
  • pregnancy
  • lactation
  • vegetarianism

Treatment and study plan

energy-restricted, CHO-restricted diet

Other

carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months

energy-restricted, CHO-rich diet

Other

carbohydrate content of diet > 55% Frequency: daily Duration: 12 months

Primary outcomes

  1. body weight

    Time frame: 12 months

Secondary outcomes

  1. waist circumference

    Time frame: 12 months

  2. blood pressure

    Time frame: 12 months

  3. blood lipids

    Time frame: 12 months

  4. parameters of glucose metabolism

    Time frame: 12 months

  5. fat mass

    Time frame: baseline, 12 months

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Mar 25, 2009
Registry last updated
Mar 22, 2017

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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