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

November 30, 2011 updated by: Maastricht University Medical Center
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homogenized Milk
900 mL homogenized milk is consumed within a mixed meal
Dietary supplement: Homogenized milk
900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Experimental: Unhomogenized Milk
900 mL unhomogenized milk is consumed within a mixed meal
Dietary supplement: Unhomogenized milk
900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Experimental: Skimmed Milk
900 mL skimmed milk and 44 g of butter are consumed within a mixed meal
Dietary supplement: Skimmed Milk
900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Dutch Dairy Association (NZO)

Investigators

  • Principal Investigator: Ronald P Mensink, PhD., Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 10-3-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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