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The effects of homogenized and unhomogenized milk on postprandial metabolism in healthy overweight me

Completed
Conditions
arteriosclerosis
atherosclerosis
hardening of the arteries
Metabolic Syndrome
insulin resistance syndrome
Syndrome X
10013317
10003216
Registration Number
NL-OMON36794
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Healthy men will be included. The inclusion criteria are
- aged between 18 and 70 years
- Quetelet index between 25 - 30 kg/m2
- mean serum triacylglycerol (<=1.7 mmol/L)
- no indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- no lactose intolerance
- no current smoker
- no familial hypercholesterolemia
- no abuse of drugs
- less than 21 alcoholic consumptions per week
- stable body weight (weight gain or loss < 3 kg in the past three months)
- no use of medication or a diet known to affect serum lipid or glucose metabolism
- no severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
- no active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- no use of an investigational product within the previous 1 month
- 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
- 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
- no difficult venipuncture as evidenced during the screening visits

Exclusion Criteria

- women
- aged <18 or >70 years
- Quetelet index below 25 or above 30 kg/m2
- mean serum triacylglycerol (>=1.7 mmol/L)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- lactose intolerant
- current smoker
- familial hypercholesterolemia
- abuse of drugs
- more than 21 alcoholic consumptions per week
- unstable 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
- not or difficult to venipuncture as evidenced during the screening visits

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter are differences in the iAUC of serum triacylglycerol<br /><br>curves. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are differences in changes in plasma markers for glucose<br /><br>metabolism, inflammatory markers, and endothelial activity, changes in<br /><br>microcirculation based on retinal imaging and changes in macrocirculation based<br /><br>on PWV measurement.</p><br>
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