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Macronutrient Relations and Weight Loss in Obese Subjects

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
energy-restricted, CHO-restricted diet
energy-restricted, CHO-rich diet
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight reduction, low-carbohydrate, body fat, telemedicine, cardiovascular risk markers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Heart Center North Rhine-Westfalia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

energy-restricted, CHO-restricted diet

energy-restricted, CHO-rich diet

Arm Description

Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months

Comparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months

Outcomes

Primary Outcome Measures

body weight

Secondary Outcome Measures

waist circumference
blood pressure
blood lipids
parameters of glucose metabolism
fat mass

Full Information

First Posted
March 24, 2009
Last Updated
March 21, 2017
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT00868387
Brief Title
Macronutrient Relations and Weight Loss in Obese Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
see brief summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight reduction, low-carbohydrate, body fat, telemedicine, cardiovascular risk markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
energy-restricted, CHO-restricted diet
Arm Type
Experimental
Arm Description
Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months
Arm Title
energy-restricted, CHO-rich diet
Arm Type
Active Comparator
Arm Description
Comparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months
Intervention Type
Other
Intervention Name(s)
energy-restricted, CHO-restricted diet
Intervention Description
carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
Intervention Type
Other
Intervention Name(s)
energy-restricted, CHO-rich diet
Intervention Description
carbohydrate content of diet > 55% Frequency: daily Duration: 12 months
Primary Outcome Measure Information:
Title
body weight
Time Frame
12 months
Secondary Outcome Measure Information:
Title
waist circumference
Time Frame
12 months
Title
blood pressure
Time Frame
12 months
Title
blood lipids
Time Frame
12 months
Title
parameters of glucose metabolism
Time Frame
12 months
Title
fat mass
Time Frame
baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinrich Koertke, PhD
Organizational Affiliation
Heart Center NRW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center North Rhine-Westfalia
City
Bad Oeynhausen
State/Province
North Rhine-Westfalia
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19615091
Citation
Frisch S, Zittermann A, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Kortke H. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovasc Diabetol. 2009 Jul 18;8:36. doi: 10.1186/1475-2840-8-36.
Results Reference
result

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Macronutrient Relations and Weight Loss in Obese Subjects

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