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

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

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

Conditions
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Hyperlipidemias, Inflammation, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Homogenized milk
* Dietary Supplement: Unhomogenized milk
* Dietary Supplement: Skimmed Milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homogenized Milk<br>900 mL homogenized milk is consumed within a mixed meal | Dietary Supplement: Homogenized milk<br>* 900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread<br>|
| Experimental: Unhomogenized Milk<br>900 mL unhomogenized milk is consumed within a mixed meal | Dietary Supplement: Unhomogenized milk<br>* 900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread<br>|
| Experimental: Skimmed Milk<br>900 mL skimmed milk and 44 g of butter are consumed within a mixed meal | Dietary Supplement: Skimmed Milk<br>* 900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area Under the triacylglycerol Curve |  | during 8 hours after meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma inflammatory markers |  | during 8 hours after meal consumption | 
| Markers of endothelial activation |  | during 8 hours after meal consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Milk, Homogenization, Postprandial hyperlipidemia, Postprandial inflammation, Overweight