The objective of the study is to compare the effects of homogenized, unhomogenized and skimmed milk with butter on postprandial metabolism in healthy overweight men.
ID
Source
Brief title
Condition
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter are differences in the iAUC of serum triacylglycerol
curves.
Secondary outcome
Secondary endpoints are differences in changes in plasma markers for glucose
metabolism, inflammatory markers, and endothelial activity, changes in
microcirculation based on retinal imaging and changes in macrocirculation based
on PWV measurement.
Background summary
Epidemiological studies have suggested that dairy products may lower the risk
to develop cardiovascular disease, even though these products can be high in
saturated fatty acids and cholesterol, which raise serum LDL cholesterol
concentrations. This apparent discrepancy may be related to beneficial effects
of dairy products on postprandial metabolism, another risk marker for
cardiovascular disease. As people spend most of the day in the postprandial
phase, this is an important finding, especially for overweight and obese
subjects who have an increased risk for postprandial metabolic disturbances.
Discrepancies, however, exist between studies. This may be related to
differences in the type of dairy products used. We now hypothesize that the
food matrix of dairy products is an important characteristic of the
postprandial response.
Study objective
The objective of the study is to compare the effects of homogenized,
unhomogenized and skimmed milk with butter on postprandial metabolism in
healthy overweight men.
Study design
Using a crossover design, subjects will receive in random order three different
meals with a washout period of at least 7 days. During the study, the
postprandial response will be measured.
Intervention
All subjects will receive in a random order three meals: a meal with
homogenized whole milk, a meal with unhomogenized whole milk, and a meal with
skimmed milk with butter. The amounts of energy will be similar for all meals.
Study burden and risks
Before the start of the study subjects will be screened to determine
eligibility during one 15 and one 10 min visit. During these visits, body
weight and height will be measured and a blood sample (3.5 mL) will be drawn by
means of venapunction. During the study, each subject will receive each of the
three test meals in random order. For this, subjects will visit the department
three times. During these visits, a photo of the retina will be taken and an
intravenous cannula will be inserted in an antecubital vein. Before and after
meal consumption, 13 blood samples (112 mL) will be drawn for the next 8 hours.
In total, 343 mL of blood will be sampled (7 mL during screening and 3x112 mL
during the study). At timepoint 0 PWV will be measured, which will be repeated
after 2, 4, 6 and 8 hours. The retinal imaging will be repeated after 4 and 8
hours. Total time investment for the subjects will be approximately 25 hours.
During this period, subjects will be at the university. On rare occasions,
blood sampling might cause bruises or haematoma.
universiteitssingel 50
6229 ER Maastricht
Nederland
universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01317524 |
| CCMO | NL35010.068.10 |