search
Back to results

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

Primary Purpose

Hyperlipidemias, Inflammation, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Homogenized milk
Unhomogenized milk
Skimmed Milk
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemias focused on measuring Milk, Homogenization, Postprandial hyperlipidemia, Postprandial inflammation, Overweight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Homogenized Milk

Unhomogenized Milk

Skimmed Milk

Arm Description

900 mL homogenized milk is consumed within a mixed meal

900 mL unhomogenized milk is consumed within a mixed meal

900 mL skimmed milk and 44 g of butter are consumed within a mixed meal

Outcomes

Primary Outcome Measures

Incremental Area Under the triacylglycerol Curve

Secondary Outcome Measures

Plasma inflammatory markers
Markers of endothelial activation

Full Information

First Posted
March 16, 2011
Last Updated
November 30, 2011
Sponsor
Maastricht University Medical Center
Collaborators
Dutch Dairy Association (NZO)
search

1. Study Identification

Unique Protocol Identification Number
NCT01317524
Brief Title
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
Official Title
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dutch Dairy Association (NZO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Inflammation, Atherosclerosis
Keywords
Milk, Homogenization, Postprandial hyperlipidemia, Postprandial inflammation, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Homogenized Milk
Arm Type
Experimental
Arm Description
900 mL homogenized milk is consumed within a mixed meal
Arm Title
Unhomogenized Milk
Arm Type
Experimental
Arm Description
900 mL unhomogenized milk is consumed within a mixed meal
Arm Title
Skimmed Milk
Arm Type
Experimental
Arm Description
900 mL skimmed milk and 44 g of butter are consumed within a mixed meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Homogenized milk
Intervention Description
900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Intervention Type
Dietary Supplement
Intervention Name(s)
Unhomogenized milk
Intervention Description
900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Intervention Type
Dietary Supplement
Intervention Name(s)
Skimmed Milk
Intervention Description
900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread
Primary Outcome Measure Information:
Title
Incremental Area Under the triacylglycerol Curve
Time Frame
during 8 hours after meal consumption
Secondary Outcome Measure Information:
Title
Plasma inflammatory markers
Time Frame
during 8 hours after meal consumption
Title
Markers of endothelial activation
Time Frame
during 8 hours after meal consumption

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs