HyperlipidemiaNCT00917878
Postprandial Effects of Milk and Milk Constituents
A study testing Milk, Protein and Calcium in people with Hyperlipidemia and Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response. 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
- Hyperlipidemia, Inflammation
- What is being tested?
- Milk, Protein and Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Jul 2009
- 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
- Body mass index (BMI) above 27 kg/m2
Who cannot join
- Smoking
- Diabetes mellitus
- Cardiovascular diseases
- Familial hypercholesterolemia or lipid lowering medication
- Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
- Unstable body weight
Show all 9Show fewer
- Abuse of alcohol or drugs
- Participation in another biomedical study during the past 30 days
- Having donated blood during the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects
The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.
- Conditions
- Hyperlipidemia, Inflammation
- Being tested
- Milk, Protein, Calcium, Control
- Keywords
- Milk, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
- Medical subject headings
- Hyperlipidemias, Inflammation, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkDietary supplement
500 mL low-fat milk added to high-fat meal
ProteinDietary supplement
Milk protein in 500 mL water added to high-fat meal
CalciumDietary supplement
Milk calcium in 500 mL water added to high-fat meal
ControlDietary supplement
Lactose in 500 mL water added to high-fat meal
| Study group | Role | What they receive |
|---|---|---|
| Milk | Experimental | 500 mL low-fat milk added to high-fat meal Receives: Dietary Supplement: Milk |
| Protein | Experimental | Milk protein in 500 mL water added to high-fat meal Receives: Dietary Supplement: Protein |
| Calcium | Experimental | Milk calcium in 500 mL water added to high-fat meal Receives: Dietary Supplement: Calcium |
| Control | Experimental | Lactose in 500 mL water added to high-fat meal (control condition) Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma inflammatory markers
Measured: 6 h after meal
Secondary outcomes (1)
Serum lipids
Measured: 6 h after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, Prof. Dr. Ir., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917878
- Sponsor's protocol ID
- MEC 08-3-096
- Status last verified
- Sep 2009
- First submitted
- 8 Jun 2009
- Last updated
- 27 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects
- ClinicalTrials.gov ID
- NCT00917878
- Acronym / sponsor ID
- MEC 08-3-096
- Conditions
- Hyperlipidemia, Inflammation
- Keywords
- Milk, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Jun 2009 (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 determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk | Experimental | Dietary Supplement: Milk500 mL low-fat milk added to high-fat meal |
| Protein | Experimental | Dietary Supplement: ProteinMilk protein in 500 mL water added to high-fat meal |
| Calcium | Experimental | Dietary Supplement: CalciumMilk calcium in 500 mL water added to high-fat meal |
| Control | Experimental | Dietary Supplement: ControlLactose in 500 mL water added to high-fat meal (control condition) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) above 27 kg/m2
Key exclusion criteria (9 listed)
- Smoking
- Diabetes mellitus
- Cardiovascular diseases
- Familial hypercholesterolemia or lipid lowering medication
- Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
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 |
|---|---|---|
| Milk500 mL low-fat milk added to high-fat meal | Dietary supplement | Milk |
| ProteinMilk protein in 500 mL water added to high-fat meal | Dietary supplement | Protein |
| CalciumMilk calcium in 500 mL water added to high-fat meal | Dietary supplement | Calcium |
| ControlLactose in 500 mL water added to high-fat meal | Dietary supplement | Control |
Primary outcome
Plasma inflammatory markers
Time frame: 6 h after meal
1 secondary outcome
Serum lipids
Time frame: 6 h after meal
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 27 Apr 2018.
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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, Prof. Dr. Ir. 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 Milk, Protein and Calcium in people with Hyperlipidemia 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 1 inclusion and 9 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 27 Apr 2018. 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?
Plasma inflammatory markers (time frame: 6 h after meal). 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 27 Apr 2018.