Differential Effects of Milk Proteins on Postprandial Lip... | NCT00819975

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

NCT00819975

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Jan 9, 2009Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Postprandial Lipemia
Type 2 Diabetes

Interventions

Casein
Whey Isolate
Whey Hydrolysate
Alphalact-Albumin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2009

Last Update Posted Date

Jan 9, 2009Estimated

Name	Class
The Danish Obesity Research Centre	OTHER
Nordic Centre of Excellence	OTHER
Arla Foods	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Casein	Dietary Supplement		Casein
Whey Isolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Triglyceride levels		0h- 2h- 4h- 6h- 7h- 8h postprandial

Secondary Outcomes

Measure	Description	Time Frame
Incretin levels		0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 Diabetes

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjeld Hermansen, Professor, MD	Department of Endocrinology and Metabolism	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Nutrition		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002364	Caseins

Ancestor Terms

ID	Term
D008894	Milk Proteins
D000080224	Animal Proteins, Dietary
D004044	Dietary Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided