Postprandial Effects of Milk and Milk Constituents | NCT00917878

Studies
Postprandial Effects of Milk and Milk Constituents

NCT00917878

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Apr 27, 2018Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Hyperlipidemia
Inflammation

Interventions

Milk
Protein
Calcium
Control

Countries

Netherlands

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

Sep 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

Mar 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jun 8, 2009

First Submission Date that Met QC Criteria

Jun 8, 2009

First Posted Date

Jun 10, 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

Apr 25, 2018

Last Update Posted Date

Apr 27, 2018Actual

Name	Class
Nederlandse Zuivel Organisatie	OTHER

Description Module

Brief Summary

The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Milk	Experimental	500 mL low-fat milk added to high-fat meal	Dietary Supplement: Milk
Protein	Experimental	Milk protein in 500 mL water added to high-fat meal	Dietary Supplement: Protein
Calcium	Experimental	Milk calcium in 500 mL water added to high-fat meal	Dietary Supplement: Calcium
Control	Experimental	Lactose in 500 mL water added to high-fat meal (control condition)	Dietary Supplement: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milk	Dietary Supplement	500 mL low-fat milk added to high-fat meal	Milk

Measure	Description	Time Frame
Plasma inflammatory markers		6 h after meal

Measure	Description	Time Frame
Serum lipids		6 h after meal

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) above 27 kg/m2

Exclusion Criteria:

Smoking
Diabetes mellitus
Cardiovascular diseases
Familial hypercholesterolemia or lipid lowering medication
Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
Unstable body weight
Abuse of alcohol or drugs
Participation in another biomedical study during the past 30 days
Having donated blood during the past 30 days

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Ronald P Mensink, Prof. Dr. Ir.	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D007249	Inflammation
D050177	Overweight

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid 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
D008892	Milk
D011506	Proteins
D002118	Calcium

Ancestor Terms

ID	Term
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D003611	Dairy Products

Browse Leaves

Not provided

Browse Branches

Not provided