Macronutrient Relations and Weight Loss in Obese Subjects

March 21, 2017 updated by: Heart and Diabetes Center North-Rhine Westfalia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see brief summary.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westfalia
      • Bad Oeynhausen, North Rhine-Westfalia, Germany, 32545
        • Heart Center North Rhine-Westfalia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 12 months
12 months
waist circumference
Time Frame: 12 months
12 months
blood lipids
Time Frame: 12 months
12 months
parameters of glucose metabolism
Time Frame: 12 months
12 months
fat mass
Time Frame: baseline, 12 months
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

  • Principal Investigator: Heinrich Koertke, PhD, Heart Center NRW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (033)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe