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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014