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

This study has been completed.
Sponsor:
Collaborators:
The Danish Obesity Research Centre
Nordic Centre of Excellence
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00817973
First received: January 6, 2009
Last updated: January 8, 2009
Last verified: January 2009
  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 proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Condition Intervention
Type 2 Diabetes
Postprandial Lipemia
Dietary Supplement: Casein
Dietary Supplement: Whey
Dietary Supplement: Cod
Dietary Supplement: Gluten

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 Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein

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
Arms Assigned Interventions
Active Comparator: Casein Dietary Supplement: Casein
Active Comparator: Whey Dietary Supplement: Whey
Active Comparator: Cod Dietary Supplement: Cod
Active Comparator: Gluten Dietary Supplement: Gluten

  Eligibility

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

Inclusion Criteria:

  • 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: NCT00817973

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

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kjeld Hermansen, Professor, Chief Physician, MD, Dr.Med.Sci, Department of Endocrinology and Metabolism, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00817973     History of Changes
Other Study ID Numbers: CERN-PPL (5A) LSM
Study First Received: January 6, 2009
Last Updated: January 8, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Whey protein
gluten
casein
cod protein
GLP-1
postprandial
triglyceride
free fatty acids
chylomicrons
retinyl palmitate
type 2 diabetes
GIP
Postprandial incretins

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

ClinicalTrials.gov processed this record on July 29, 2014