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Postprandial Effects of Milk and Milk Constituents

This study has been completed.
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00917878
First received: June 8, 2009
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  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: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Plasma inflammatory markers [ Time Frame: 6 h after meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum lipids [ Time Frame: 6 h after meal ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 8, 2009
Last Updated: September 17, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 19, 2013