The Effects of Homogenized and Unhomogenized Milk on Post... | NCT01317524

Studies
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men

NCT01317524

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Dec 1, 2011Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Hyperlipidemias
Inflammation
Atherosclerosis

Interventions

Homogenized milk
Unhomogenized milk
Skimmed Milk

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

Nov 2011

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

Feb 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

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

Nov 30, 2011

Last Update Posted Date

Dec 1, 2011Estimated

Name	Class
Dutch Dairy Association (NZO)	UNKNOWN

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

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Homogenized Milk	Experimental	900 mL homogenized milk is consumed within a mixed meal	Dietary Supplement: Homogenized milk
Unhomogenized Milk	Experimental	900 mL unhomogenized milk is consumed within a mixed meal	Dietary Supplement: Unhomogenized milk
Skimmed Milk	Experimental	900 mL skimmed milk and 44 g of butter are consumed within a mixed meal	Dietary Supplement: Skimmed Milk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Homogenized milk	Dietary Supplement	900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread	Homogenized Milk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incremental Area Under the triacylglycerol Curve		during 8 hours after meal consumption

Secondary Outcomes

Measure	Description	Time Frame
Plasma inflammatory markers		during 8 hours after meal consumption
Markers of endothelial activation		during 8 hours after meal consumption

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men
aged between 18 and 70 years
Quetelet index between 25 - 30 kg/m2
mean serum triacylglycerol (≤1.7 mmol/L (31))

Exclusion Criteria:

women
indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
lactose intolerance
current smoker
familial hypercholesterolemia
abuse of drugs
more than 21 alcoholic consumptions per week
no stable body weight (weight gain or loss < 3 kg in the past three months)
use of medication or a diet known to affect serum lipid or glucose metabolism
severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
use of an investigational product within the previous 1 month
not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
difficult venipuncture as evidenced during the screening visits

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

Name	Affiliation	Role
Ronald P Mensink, PhD.	Maastricht University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht	Limburg	6200 MD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D007249	Inflammation
D050197	Atherosclerosis
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