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

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ClinicalTrials.gov Identifier: NCT00819975
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : January 9, 2009
Sponsor:
Collaborators:
The Danish Obesity Research Centre
Nordic Centre of Excellence
Arla Foods
Information provided by:
Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Postprandial Lipemia Type 2 Diabetes Dietary Supplement: Casein Dietary Supplement: Whey Isolate Dietary Supplement: Whey Hydrolysate Dietary Supplement: Alphalact-Albumin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

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



Primary Outcome Measures :
  1. Triglyceride levels [ Time Frame: 0h- 2h- 4h- 6h- 7h- 8h postprandial ]

Secondary Outcome Measures :
  1. Incretin levels [ Time Frame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819975


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

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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
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

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

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