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Macronutrient Relations and Weight Loss in Obese Subjects

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ClinicalTrials.gov Identifier: NCT00868387
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Other: energy-restricted, CHO-restricted diet Other: energy-restricted, CHO-rich diet Not Applicable

Detailed Description:
see brief summary.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

Publications of Results:
Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT00868387     History of Changes
Other Study ID Numbers: 003
First Posted: March 25, 2009    Key Record Dates
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