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Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

Primary Purpose

Postprandial Lipemia, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Casein
Whey Isolate
Whey Hydrolysate
Alphalact-Albumin
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Lipemia focused on measuring Casein, Whey, postprandial, Triglyceride, Free fatty acids, Retinyl palmitate, Incretins, Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Type 2 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 Isolate

Whey Hydrolysate

Alphalact-Albumin

Arm Description

Outcomes

Primary Outcome Measures

Triglyceride levels

Secondary Outcome Measures

Incretin levels

Full Information

First Posted
January 8, 2009
Last Updated
January 8, 2009
Sponsor
Aarhus University Hospital
Collaborators
The Danish Obesity Research Centre, Nordic Centre of Excellence, Arla Foods
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1. Study Identification

Unique Protocol Identification Number
NCT00819975
Brief Title
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes
Official Title
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes
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
May 2008 (Actual)

3. Sponsor/Collaborators

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

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 milk proteins casein, Whey Isolate, Whey Hydrolysate, and Alphalact-Albumin 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
Postprandial Lipemia, Type 2 Diabetes
Keywords
Casein, Whey, postprandial, Triglyceride, Free fatty acids, Retinyl palmitate, Incretins, Type 2 Diabetes

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 Isolate
Arm Type
Active Comparator
Arm Title
Whey Hydrolysate
Arm Type
Active Comparator
Arm Title
Alphalact-Albumin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Isolate
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Hydrolysate
Intervention Type
Dietary Supplement
Intervention Name(s)
Alphalact-Albumin
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: Type 2 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
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

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