- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817973
Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.
The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark
- Department of Clinical Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes
Exclusion Criteria:
- Liver, Kidney- and/or Heart Disease
- Serious Hypertension (160/110 mmHg)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Casein
|
|
Active Comparator: Whey
|
|
Active Comparator: Cod
|
|
Active Comparator: Gluten
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Triglyceride levels
Time Frame: 0h- 2h- 4h- 6h- 7h- 8h postprandial
|
0h- 2h- 4h- 6h- 7h- 8h postprandial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incretin levels
Time Frame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
|
0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kjeld Hermansen, Professor, MD, Department of Endocrinology and Metabolism
Publications and helpful links
General Publications
- Mortensen LS, Thomsen C, Hermansen K. Effects of different protein sources on plasminogen inhibitor-1 and factor VII coagulant activity added to a fat-rich meal in type 2 diabetes. Rev Diabet Stud. 2010 Fall;7(3):233-40. doi: 10.1900/RDS.2010.7.233. Epub 2010 Nov 10.
- Mortensen LS, Hartvigsen ML, Brader LJ, Astrup A, Schrezenmeir J, Holst JJ, Thomsen C, Hermansen K. Differential effects of protein quality on postprandial lipemia in response to a fat-rich meal in type 2 diabetes: comparison of whey, casein, gluten, and cod protein. Am J Clin Nutr. 2009 Jul;90(1):41-8. doi: 10.3945/ajcn.2008.27281. Epub 2009 May 20.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERN-PPL (5A) LSM
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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