Macronutrient Relations and Weight Loss in Obese Subjects

This study has been completed.
Sponsor:
Information provided by:
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT00868387
First received: March 24, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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
Obesity
Other: energy-restricted, carbohydrate-restricted diet
Other: energy-restricted, fat-restricted diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
  • fat mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • blood lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • parameters of glucose metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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: carbohydrate restriction
Interventions: carbohydrate content of diet: < 40% Frequency: daily Duration: 12 months
Other: energy-restricted, carbohydrate-restricted diet
carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
Active Comparator: fat restriction
Interventions: carbohydrate content of diet > 55% Frequency: daily Duration: 12 months
Other: energy-restricted, fat-restricted diet
carbohydrate content of diet > 55% Frequency: daily Duration: 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00868387

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

Publications:
Responsible Party: Heinrich Koertke, PhD, Heart Center NRW
ClinicalTrials.gov Identifier: NCT00868387     History of Changes
Other Study ID Numbers: 003
Study First Received: March 24, 2009
Last Updated: December 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014