- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863564
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
November 9, 2009 updated by: Aarhus University Hospital
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.
Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
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
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-
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Aarhus, Denmark, 8000
- Department of Clinical Nutrion
-
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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
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 30 kg/m2 & < 45 kg/m2
Exclusion Criteria:
- Diabetes
- Lipid lowering drugs
- Liver-, Kidney- and/or Heart Disease
- Serious Hypertension (160/110)
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cod
|
|
Active Comparator: Gluten
|
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Active Comparator: Whey Isolate
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Active Comparator: Caseine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Triglyceride
Time Frame: 0h- 2h- 4h- 6h- 8h postprandial
|
0h- 2h- 4h- 6h- 8h postprandial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incretins
Time Frame: 0h -1h -2h -4h -6h -8h Postprandial
|
0h -1h -2h -4h -6h -8h Postprandial
|
Inflammatory markers
Time Frame: 0h- 1h- 2h- 4h- 6h- 8h postprandial
|
0h- 1h- 2h- 4h- 6h- 8h postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: K Hermansen, Professor, MD, Department of Endocrinology and Metabolism, Aarhus University Hospital
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
March 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Estimate)
November 10, 2009
Last Update Submitted That Met QC Criteria
November 9, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERN-PPL-JHJ-5a
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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