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Macronutrient Relations and Weight Loss in Obese Subjects

This study has been completed.
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia Identifier:
First received: March 24, 2009
Last updated: March 21, 2017
Last verified: December 2013
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.

Condition Intervention
Other: energy-restricted, CHO-restricted diet
Other: energy-restricted, CHO-rich diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Resource links provided by NLM:

Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • body weight [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • waist circumference [ Time Frame: 12 months ]
  • blood pressure [ Time Frame: 12 months ]
  • blood lipids [ Time Frame: 12 months ]
  • parameters of glucose metabolism [ Time Frame: 12 months ]
  • fat mass [ Time Frame: baseline, 12 months ]

Enrollment: 200
Study Start Date: November 2005
Study Completion Date: December 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: energy-restricted, CHO-restricted diet
Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months
Other: energy-restricted, CHO-restricted diet
carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
Active Comparator: energy-restricted, CHO-rich diet
Comparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months
Other: energy-restricted, CHO-rich diet
carbohydrate content of diet > 55% Frequency: daily Duration: 12 months

Detailed Description:
see brief summary.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00868387

Heart Center North Rhine-Westfalia
Bad Oeynhausen, North Rhine-Westfalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Principal Investigator: Heinrich Koertke, PhD Heart Center NRW
  More Information

Responsible Party: Heart and Diabetes Center North-Rhine Westfalia Identifier: NCT00868387     History of Changes
Other Study ID Numbers: 003
Study First Received: March 24, 2009
Last Updated: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
weight reduction
body fat
cardiovascular risk markers

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms processed this record on May 25, 2017