search
Back to results

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

Primary Purpose

Type 2 Diabetes, Postprandial Lipemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Casein
Whey
Cod
Gluten
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Whey protein, gluten, casein, cod protein, GLP-1, postprandial, triglyceride, free fatty acids, chylomicrons, retinyl palmitate, type 2 diabetes, GIP, Postprandial incretins

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Liver, Kidney- and/or Heart Disease
  • Serious Hypertension (160/110 mmHg)

Sites / Locations

  • Department of Clinical Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Casein

Whey

Cod

Gluten

Arm Description

Outcomes

Primary Outcome Measures

Triglyceride levels

Secondary Outcome Measures

Incretin levels

Full Information

First Posted
January 6, 2009
Last Updated
January 8, 2009
Sponsor
Aarhus University Hospital
Collaborators
The Danish Obesity Research Centre, Nordic Centre of Excellence
search

1. Study Identification

Unique Protocol Identification Number
NCT00817973
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital
Collaborators
The Danish Obesity Research Centre, Nordic Centre of Excellence

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Postprandial Lipemia
Keywords
Whey protein, gluten, casein, cod protein, GLP-1, postprandial, triglyceride, free fatty acids, chylomicrons, retinyl palmitate, type 2 diabetes, GIP, Postprandial incretins

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Casein
Arm Type
Active Comparator
Arm Title
Whey
Arm Type
Active Comparator
Arm Title
Cod
Arm Type
Active Comparator
Arm Title
Gluten
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey
Intervention Type
Dietary Supplement
Intervention Name(s)
Cod
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten
Primary Outcome Measure Information:
Title
Triglyceride levels
Time Frame
0h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary Outcome Measure Information:
Title
Incretin levels
Time Frame
0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes Exclusion Criteria: Liver, Kidney- and/or Heart Disease Serious Hypertension (160/110 mmHg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Hermansen, Professor, MD
Organizational Affiliation
Department of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Nutrition
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21409315
Citation
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.
Results Reference
derived
PubMed Identifier
19458012
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs