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Postprandial Effects of Milk and Milk Constituents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917878
First Posted: June 10, 2009
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Hyperlipidemia Inflammation Dietary Supplement: Milk Dietary Supplement: Protein Dietary Supplement: Calcium Dietary Supplement: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Plasma inflammatory markers [ Time Frame: 6 h after meal ]

Secondary Outcome Measures:
  • Serum lipids [ Time Frame: 6 h after meal ]

Estimated Enrollment: 16
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917878


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Nederlandse Zuivel Organisatie
Investigators
Principal Investigator: Ronald P Mensink, Prof. Dr. Ir. Maastricht University Medical Center
  More Information

Responsible Party: Prof. Dr. Ir. Ronald P. Mensink, Maastricht Universtity Medical Center
ClinicalTrials.gov Identifier: NCT00917878     History of Changes
Other Study ID Numbers: MEC 08-3-096
First Submitted: June 8, 2009
First Posted: June 10, 2009
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Maastricht University Medical Center:
Milk
Postprandial hyperlipidemia
Postprandial inflammation
Overweight

Additional relevant MeSH terms:
Inflammation
Hyperlipidemias
Hyperlipoproteinemias
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs