HyperlipidemiasNCT01317524
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
A study testing Homogenized milk, Unhomogenized milk and Skimmed Milk in people with Hyperlipidemias and Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Inflammation, Atherosclerosis
- What is being tested?
- Homogenized milk, Unhomogenized milk and Skimmed Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men
- aged between 18 and 70 years
- Quetelet index between 25 - 30 kg/m2
- mean serum triacylglycerol (≤1.7 mmol/L (31))
Who cannot join
- women
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
- lactose intolerance
- current smoker
- familial hypercholesterolemia
- abuse of drugs
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6200 MD
About this study
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men
- Conditions
- Hyperlipidemias, Inflammation, Atherosclerosis
- Being tested
- Homogenized milk, Unhomogenized milk, Skimmed Milk
- Keywords
- Milk, Homogenization, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
- Medical subject headings
- Hyperlipidemias, Inflammation, Atherosclerosis, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homogenized milkDietary supplement
900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Unhomogenized milkDietary supplement
900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
Skimmed MilkDietary supplement
900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread
| Study group | Role | What they receive |
|---|---|---|
| Homogenized Milk | Experimental | 900 mL homogenized milk is consumed within a mixed meal Receives: Dietary Supplement: Homogenized milk |
| Unhomogenized Milk | Experimental | 900 mL unhomogenized milk is consumed within a mixed meal Receives: Dietary Supplement: Unhomogenized milk |
| Skimmed Milk | Experimental | 900 mL skimmed milk and 44 g of butter are consumed within a mixed meal Receives: Dietary Supplement: Skimmed Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the triacylglycerol Curve
Measured: during 8 hours after meal consumption
Secondary outcomes (2)
Plasma inflammatory markers
Measured: during 8 hours after meal consumption
Markers of endothelial activation
Measured: during 8 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Dairy Association (NZO)
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317524
- Sponsor's protocol ID
- MEC 10-3-089
- Status last verified
- Nov 2011
- First submitted
- 16 Mar 2011
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
- ClinicalTrials.gov ID
- NCT01317524
- Acronym / sponsor ID
- MEC 10-3-089
- Conditions
- Hyperlipidemias, Inflammation, Atherosclerosis
- Keywords
- Milk, Homogenization, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Dairy Association (NZO)
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homogenized Milk | Experimental | Dietary Supplement: Homogenized milk900 mL homogenized milk is consumed within a mixed meal |
| Unhomogenized Milk | Experimental | Dietary Supplement: Unhomogenized milk900 mL unhomogenized milk is consumed within a mixed meal |
| Skimmed Milk | Experimental | Dietary Supplement: Skimmed Milk900 mL skimmed milk and 44 g of butter are consumed within a mixed meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men
- aged between 18 and 70 years
- Quetelet index between 25 - 30 kg/m2
- mean serum triacylglycerol (≤1.7 mmol/L (31))
Key exclusion criteria (15 listed)
- women
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
- lactose intolerance
- current smoker
- familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homogenized milk900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread | Dietary supplement | Homogenized Milk |
| Unhomogenized milk900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread | Dietary supplement | Unhomogenized Milk |
| Skimmed Milk900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread | Dietary supplement | Skimmed Milk |
Primary outcome
Incremental Area Under the triacylglycerol Curve
Time frame: during 8 hours after meal consumption
2 secondary outcomes
Plasma inflammatory markers
Time frame: during 8 hours after meal consumption
Markers of endothelial activation
Time frame: during 8 hours after meal consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald P Mensink, PhD. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homogenized milk, Unhomogenized milk and Skimmed Milk in people with Hyperlipidemias and Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Area Under the triacylglycerol Curve (time frame: during 8 hours after meal consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.