HypercholesterolemiaMFGMNCT01767077
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
A study testing Butter oil and Cream in people with Hypercholesterolemia, run by Uppsala University at 1 site in Sweden.
Trial summary
Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Butter oil and Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Jun 2013
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-37
- LDL-cholesterol 2.0-4.5 mmol/l
Who cannot join
- Use of lipid lowering drugs
- Diagnosed cardiovascular disease or diabetes
- Use of extreme diets
- Food allergies relevant to the study
- Pregnancy or active lactation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
Uppsala
About this study
Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
Read the detailed description
Dairy foods are a major component of the nordic diet. Epidemiological data suggest potential health effects of dairy foods with regard to obesity related disorders. Low-fat dairy foods have shown to be protective, but also high-fat products have been linked to reduced risk in some studies. It is well known that dairy products increase LDL-cholesterol in blood, but effects on glucose metabolism are unclear. Intervention trials are needed to clarify the health effects of dairy foods. Some data have indicated that cheese and milk may have less hypercholesterolemic effect compared with butter. Our hypothesis is that milk fat globule membranes (MFGM), present in all dairy products except butter, can affect blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Such idea might explain why different dairy products could have different effects on cholesterol levels. The investigators aim to conduct a controlled study to investigate this. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
- Conditions
- Hypercholesterolemia
- Being tested
- Butter oil, Cream
- Keywords
- Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butter oilDietary supplement
Daily intake of 40 g butter oil
CreamDietary supplement
Daily intake of 100 g cream (40%)
| Study group | Role | What they receive |
|---|---|---|
| Butter oil | Placebo comparator | Daily intake of 40 g butter oil Receives: Dietary Supplement: Butter oil |
| Cream | Active comparator | Daily intake of 100 g cream (40%) Receives: Dietary Supplement: Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Measured: 8 weeks
Secondary outcomes (4)
Other major blood lipids
HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
Measured: 8 weeks
Homeostasis model of assessment - insulin resistance
Insulin and glucose
Measured: 8 weeks
Peripheral blood mononuclear cell gene expression
Measured: 8 weeks
Inflammatory markers
C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, LRF Mjölk, Sweden, Arla Foods, Skånemejerier, Sweden, Semper AB, Sweden, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Swedish Nutrition Foundation SNF, Vinnova, The Swedish Farmers' Foundation for Agricultural Research, Livsmedelsföretagen, Sweden, Svensk Dagligvaruhandel, Sweden
- Responsible party
- Sponsor
- Investigators
- Ulf Risérus, Assoc prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767077
- Sponsor's protocol ID
- TvärLivs-MFGM
- Acronym
- MFGM
- Status last verified
- Sep 2013
- First submitted
- 9 Jan 2013
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosqvist F, Smedman A, Lindmark-Mansson H, Paulsson M, Petrus P, Straniero S, Rudling M, Dahlman I, Riserus U. Potential role of milk fat globule membrane in modulating plasma lipoproteins, gene expression, and cholesterol metabolism in humans: a randomized study. Am J Clin Nutr. 2015 Jul;102(1):20-30. doi: 10.3945/ajcn.115.107045. Epub 2015 May 27.
PubMed 26016870
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
- ClinicalTrials.gov ID
- NCT01767077
- Acronym / sponsor ID
- MFGM / TvärLivs-MFGM
- Conditions
- Hypercholesterolemia
- Keywords
- Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Lund University, LRF Mjölk, Sweden, Arla Foods, Skånemejerier, Sweden, Semper AB, Sweden, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Swedish Nutrition Foundation SNF, Vinnova, The Swedish Farmers' Foundation for Agricultural Research, Livsmedelsföretagen, Sweden, Svensk Dagligvaruhandel, Sweden
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jan 2013 (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.
Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
Detailed description
Dairy foods are a major component of the nordic diet. Epidemiological data suggest potential health effects of dairy foods with regard to obesity related disorders. Low-fat dairy foods have shown to be protective, but also high-fat products have been linked to reduced risk in some studies. It is well known that dairy products increase LDL-cholesterol in blood, but effects on glucose metabolism are unclear. Intervention trials are needed to clarify the health effects of dairy foods. Some data have indicated that cheese and milk may have less hypercholesterolemic effect compared with butter. Our hypothesis is that milk fat globule membranes (MFGM), present in all dairy products except butter, can affect blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Such idea might explain why different dairy products could have different effects on cholesterol levels. The investigators aim to conduct a controlled study to investigate this. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butter oil | Placebo comparator | Dietary Supplement: Butter oilDaily intake of 40 g butter oil |
| Cream | Active comparator | Dietary Supplement: CreamDaily intake of 100 g cream (40%) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 25-37
- LDL-cholesterol 2.0-4.5 mmol/l
Key exclusion criteria (5 listed)
- Use of lipid lowering drugs
- Diagnosed cardiovascular disease or diabetes
- Use of extreme diets
- Food allergies relevant to the study
- Pregnancy or active lactation
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 |
|---|---|---|
| Butter oilDaily intake of 40 g butter oil | Dietary supplement | Butter oil |
| CreamDaily intake of 100 g cream (40%) | Dietary supplement | Cream |
Primary outcome
LDL-cholesterol
Time frame: 8 weeks
4 secondary outcomes
Other major blood lipids
Time frame: 8 weeks
Homeostasis model of assessment - insulin resistance
Time frame: 8 weeks
Peripheral blood mononuclear cell gene expression
Time frame: 8 weeks
Inflammatory markers
Time frame: 8 weeks
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 25 Sep 2013.
- Derived from this study: PubMed 26016870Rosqvist F, Smedman A, Lindmark-Mansson H, Paulsson M, Petrus P, Straniero S, Rudling M, Dahlman I, Riserus U. Potential role of milk fat globule membrane in modulating plasma lipoproteins, gene expression, and cholesterol metabolism in humans: a randomized study. Am J Clin Nutr. 2015 Jul;102(1):20-30. doi: 10.3945/ajcn.115.107045. Epub 2015 May 27.
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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.
Ulf Risérus, Assoc prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butter oil and Cream in people with Hypercholesterolemia, run by Uppsala University at 1 site in Sweden.
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 2 inclusion and 5 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 25 Sep 2013. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
LDL-cholesterol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767077, which also lists 1 linked publication.
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 25 Sep 2013.