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

Not Applicable

Completed

• Conditions: Hyperlipidemias; Inflammation; Atherosclerosis
• Interventions: Dietary Supplement: Homogenized milk; Dietary Supplement: Unhomogenized milk; Dietary Supplement: Skimmed Milk

• Registration Number: NCT01317524
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Homogenized Milk	Homogenized milk	900 mL homogenized milk is consumed within a mixed meal
Unhomogenized Milk	Unhomogenized milk	900 mL unhomogenized milk is consumed within a mixed meal
Skimmed Milk	Skimmed Milk	900 mL skimmed milk and 44 g of butter are consumed within a mixed meal

Primary Outcome Measures

Name	Time	Method
Incremental Area Under the triacylglycerol Curve	during 8 hours after meal consumption

Secondary Outcome Measures

Name	Time	Method
Plasma inflammatory markers	during 8 hours after meal consumption
Markers of endothelial activation	during 8 hours after meal consumption

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands