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Macronutrient Relations and Weight Loss in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868387
First Posted: March 25, 2009
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
  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, CHO-restricted diet Other: energy-restricted, CHO-rich diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT00868387     History of Changes
Other Study ID Numbers: 003
First Submitted: March 24, 2009
First Posted: March 25, 2009
Last Update Posted: March 22, 2017
Last Verified: December 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Changes
Body Weight
Signs and Symptoms