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

January 8, 2009 updated by: Aarhus University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Clinical Nutrition

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes

Exclusion Criteria:

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Casein
Dietary supplement: Casein
Active Comparator: Whey Isolate
Dietary supplement: Whey Isolate
Active Comparator: Whey Hydrolysate
Dietary supplement: Whey Hydrolysate
Active Comparator: Alphalact-Albumin
Dietary supplement: Alphalact-Albumin

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

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Arla Foods
The Danish Obesity Research Centre
Nordic Centre of Excellence

Investigators

  • Principal Investigator: Kjeld Hermansen, Professor, MD, Department of Endocrinology and Metabolism

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 Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERN-PPL (5B) 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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