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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01317524

Collaborator

Dutch Dairy Association (NZO) (Other)

Enrollment

Location

Arms

3.9

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias Inflammation Atherosclerosis	Dietary Supplement: Homogenized milk Dietary Supplement: Unhomogenized milk Dietary Supplement: Skimmed Milk	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Incremental Area Under the triacylglycerol Curve [during 8 hours after meal consumption]

Secondary Outcome Measures

Plasma inflammatory markers [during 8 hours after meal consumption]
Markers of endothelial activation [during 8 hours after meal consumption]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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