Postprandial Effects of Milk and Milk Constituents

April 25, 2018 updated by: Maastricht University Medical Center

The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
      • Maastricht, Netherlands
        • 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

Yes

Genders Eligible for Study

Male

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Milk
500 mL low-fat milk added to high-fat meal
Dietary supplement: Milk
500 mL low-fat milk added to high-fat meal
Experimental: Protein
Milk protein in 500 mL water added to high-fat meal
Dietary supplement: Protein
Milk protein in 500 mL water added to high-fat meal
Experimental: Calcium
Milk calcium in 500 mL water added to high-fat meal
Dietary supplement: Calcium
Milk calcium in 500 mL water added to high-fat meal
Experimental: Control
Lactose in 500 mL water added to high-fat meal (control condition)
Dietary supplement: Control
Lactose in 500 mL water added to high-fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma inflammatory markers
Time Frame: 6 h after meal
6 h after meal

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum lipids
Time Frame: 6 h after meal
6 h after meal

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Nederlandse Zuivel Organisatie

Investigators

  • Principal Investigator: Ronald P Mensink, Prof. Dr. Ir., 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

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 08-3-096

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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