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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Inflammation; Hyperlipidemias; Atherosclerosis

Treatments: Dietary Supplement: Unhomogenized milk; Dietary Supplement: Homogenized milk; Dietary Supplement: Skimmed Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01317524

MEC 10-3-089

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 3 patient groups

Homogenized Milk

Experimental group

Description:

900 mL homogenized milk is consumed within a mixed meal

Treatment:

Dietary Supplement: Homogenized milk

Unhomogenized Milk

Experimental group

Description:

900 mL unhomogenized milk is consumed within a mixed meal

Treatment:

Dietary Supplement: Unhomogenized milk

Skimmed Milk

Experimental group

Description:

900 mL skimmed milk and 44 g of butter are consumed within a mixed meal

Treatment:

Dietary Supplement: Skimmed Milk