The effects of homogenized and unhomogenized milk on postprandial metabolism in healthy overweight me
- Conditions
- arteriosclerosisatherosclerosishardening of the arteriesMetabolic Syndromeinsulin resistance syndromeSyndrome X1001331710003216
- 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
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
- 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
Name Time Method <p>The main study parameter are differences in the iAUC of serum triacylglycerol<br /><br>curves. </p><br>
- Secondary Outcome Measures
Name Time Method <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>