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

This study has been completed.
Sponsor:
Collaborator:
Dutch Dairy Association (NZO)
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01317524
First received: March 16, 2011
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men


Condition Intervention
Hyperlipidemias
Inflammation
Atherosclerosis
Dietary Supplement: Homogenized milk
Dietary Supplement: Unhomogenized milk
Dietary Supplement: Skimmed Milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Incremental Area Under the triacylglycerol Curve [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma inflammatory markers [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]
  • Markers of endothelial activation [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01317524

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Dairy Association (NZO)
Investigators
Principal Investigator: Ronald P Mensink, PhD. Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01317524     History of Changes
Other Study ID Numbers: MEC 10-3-089
Study First Received: March 16, 2011
Last Updated: November 30, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Hyperlipidemias
Inflammation
Overweight
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014