- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868387
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
-
-
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
|
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
|
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.
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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003 (NuSkin International)
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.
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