NCT00819975

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
Last Updated

January 9, 2009

Status Verified

January 1, 2009

First QC Date

January 8, 2009

Last Update Submit

January 8, 2009

Conditions

Postprandial LipemiaType 2 Diabetes

Keywords

CaseinWheypostprandialTriglycerideFree fatty acidsRetinyl palmitateIncretinsType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Triglyceride levels

    0h- 2h- 4h- 6h- 7h- 8h postprandial

Secondary Outcomes (1)

  • Incretin levels

    0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial

Study Arms (4)

Casein

ACTIVE COMPARATOR
Dietary Supplement: Casein

Whey Isolate

ACTIVE COMPARATOR
Dietary Supplement: Whey Isolate

Whey Hydrolysate

ACTIVE COMPARATOR
Dietary Supplement: Whey Hydrolysate

Alphalact-Albumin

ACTIVE COMPARATOR
Dietary Supplement: Alphalact-Albumin

Interventions

CaseinDIETARY_SUPPLEMENT
Casein
Whey IsolateDIETARY_SUPPLEMENT
Whey Isolate
Whey HydrolysateDIETARY_SUPPLEMENT
Whey Hydrolysate
Alphalact-AlbuminDIETARY_SUPPLEMENT
Alphalact-Albumin

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Nutrition

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Caseins

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteins

Study Officials

  • Kjeld Hermansen, Professor, MD

    Department of Endocrinology and Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Completion

May 1, 2008

Last Updated

January 9, 2009

Record last verified: 2009-01

Locations

DK(1)