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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317524
• Other study ID #: MEC 10-3-089
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: November 30, 2011
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Hyperlipidemias
• Inflammation
• Overweight

Intervention

Dietary Supplement:
• Homogenized milk
900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
• Unhomogenized milk
900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
• Skimmed Milk
900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Dairy Association (NZO)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Area Under the triacylglycerol Curve		during 8 hours after meal consumption	No
Secondary	Plasma inflammatory markers		during 8 hours after meal consumption	No
Secondary	Markers of endothelial activation		during 8 hours after meal consumption	No