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

This study has been completed.
Sponsor:
Collaborators:
The Danish Obesity Research Centre
Nordic Centre of Excellence
Arla Foods
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00819975
First received: January 8, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Postprandial Lipemia
Type 2 Diabetes
Dietary Supplement: Casein
Dietary Supplement: Whey Isolate
Dietary Supplement: Whey Hydrolysate
Dietary Supplement: Alphalact-Albumin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Triglyceride levels [ Time Frame: 0h- 2h- 4h- 6h- 7h- 8h postprandial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incretin levels [ Time Frame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial ] [ Designated as safety issue: No ]

Enrollment: 12
Study Completion Date: May 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes

Exclusion Criteria:

  • Liver-, Kidney- and/or Heart Disease
  • Serious Hypertension (160/110 mmHg)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819975

Locations
Denmark
Department of Clinical Nutrition
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
The Danish Obesity Research Centre
Nordic Centre of Excellence
Arla Foods
Investigators
Principal Investigator: Kjeld Hermansen, Professor, MD Department of Endocrinology and Metabolism
  More Information

No publications provided

Responsible Party: Kjeld Hermansen, Professor, Chief Physician, MD, Dr.Med.Sci, Department of Endocrinology and Metabolism, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00819975     History of Changes
Other Study ID Numbers: CERN-PPL (5B) LSM
Study First Received: January 8, 2009
Last Updated: January 8, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Casein
Whey
postprandial
Triglyceride
Free fatty acids
Retinyl palmitate
Incretins
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Dyslipidemias
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on October 23, 2014