Postprandial Lipid MetabolismNCT06340412
Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
A study testing Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch., Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. and Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. in people with Postprandial Lipid Metabolism, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans. The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Lipid Metabolism
- What is being tested?
- Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch., Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. and Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2024to 1 Mar 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- Written and informed consent
- HbA1c < 48 mmol/l
Who cannot join
- Medicine with an impact on blood glucose, lipid profile, or blood pressure and birth control pills
- BMI > 30kg/m2
- Affected screening blood sample as evaluated by the clinical responsible investigator
- Severe claustrophobia
- Lactose intolerance
- Doesn't speak and understand Danish
- Commitment to special diets
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center Aarhus, Aarhus University Hospital
Aarhus, 8200
About this study
The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.
Read the detailed description
The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume two high-fat meals composed of milk fat with intact MFGM, destroyed MFGM, and without MFGM, respectively. The first meal will be consumed as breakfast and the second meal will be consumed as lunch. Test meals will be isocaloric and with similar macronutrient composition. The meal will consist of a sandwich with a butter-like dairy product.
The three trial days will be completely alike, besides the interventions.
Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize.
The participants will have one intravenous (iv.) access placed in the elbow on the three trial days where blood samples will be collected at 15, 30, 60, 90, 120, 150 and 180 min after each test meal (breakfast and lunch).
Immediately after consuming each of the two test meals, the subjects will take 1,500mg paracetamol to determine ventricular emptying rate using the acetaminophen test. After this, the subjects can lay in the bed and watch TV, iPad, or work on their laptop.
Before and every hour after consumption of the test meals, the subjects will be asked to fill out an appetite questionnaire (visual analogue scale). At the end of the day the participants will be offered an "ad libitum meal" to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.
An one-way mixed model of linear regression will be used to compare postprandial area under the curve, ventricular emptying, and ad libitum food intake between the three test days. Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements.
Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides (20), the investigators will need 11 subjects to detect a 15% decrease in postprandial triglyceride AUC (α=0.05, β=0.80). To account for potential missing values, 12 subjects will be included in total.
- Conditions
- Postprandial Lipid Metabolism
- Being tested
- Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch., Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch., Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.
- Keywords
- Milk fat globule membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch.Dietary supplement
- Sandwich with butter-like dairy product (40g milk fat) with intact MFGM.
Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch.Dietary supplement
- Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM.
Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.Dietary supplement
- Sandwich with butter-like dairy product (40g milk fat) without MFGM.
| Study group | Role | What they receive |
|---|---|---|
| High-fat meal with intact MFGM | Experimental | Not described Receives: Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch. |
| High-fat meal with destroyed MFGM | Experimental | Not described Receives: Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. |
| High-fat meal without MFGM | Experimental | Not described Receives: Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in postprandial triglycerides measured as area under the curve (AUC).
Difference in triglycerides AUC after the intervention between high-fat meal with intact MFGM, high-fat meal with destroyed MFGM, and high-fat meal without MFGM.
Measured: -60 to 180 minutes after first intervention (first meal), 0-180 minuter after second intervention (second high-fat meal)
Secondary outcomes (21)
Difference in concentration of GLP-1
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of Ghrelin
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of LEAP2
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of FFA
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of Insulin
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of glucagon
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of cholesterol (total, LDL and HDL)
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of GIP
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of CCK
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of Gastrin
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of GDF15
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein)
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of Cytokines
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of apoB48
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of apoB100
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in glucose concentration
Continuous glucose monitoring (CGM)
Measured: -60 to 360 minutes after first intervention (first high-fat meal)
Difference in appetite sensation
Visual analogue scale (VAS)
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in gastric emptying rate
Acetaminophen test
Measured: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Ad libitum meal test
Amount of food (in grams) intake at the end of the test day to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.
Measured: 420 minutes after start of test day.
Metabolic rate
Indirect calorimetry
Measured: 0-420 minutes
Substrate metabolism
Indirect calorimetry
Measured: 0-420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start11 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
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 Postprandial Lipid MetabolismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Not applicable
- Intervention model
- Crossover
- Model description
- A randomized, double-blinded, controlled, crossover trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Sponsor
- Investigators
- Esben Søndergaard, MD, PhD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340412
- Sponsor's protocol ID
- MFGM-FOR-HEALTH
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voigt JH, Zubanovic NB, Moller AB, Suwal SK, Andersen U, Andersen HJ, Rittig N, Sondergaard E. Milk Fat Globule Membrane in a Novel High-Fat Spread Does Not Acutely Affect Postprandial Lipidemia in Healthy Individuals-A Randomized, Double-Blind Crossover Trial. J Nutr. 2026 Aug;156(8):101647. doi: 10.1016/j.tjnut.2026.101647. Epub 2026 Jun 6.
PubMed 42251897
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06340412
- Acronym / sponsor ID
- MFGM-FOR-HEALTH
- Conditions
- Postprandial Lipid Metabolism
- Keywords
- Milk fat globule membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- 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 aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.
Detailed description
The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume two high-fat meals composed of milk fat with intact MFGM, destroyed MFGM, and without MFGM, respectively. The first meal will be consumed as breakfast and the second meal will be consumed as lunch. Test meals will be isocaloric and with similar macronutrient composition. The meal will consist of a sandwich with a butter-like dairy product.
The three trial days will be completely alike, besides the interventions.
Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize.
The participants will have one intravenous (iv.) access placed in the elbow on the three trial days where blood samples will be collected at 15, 30, 60, 90, 120, 150 and 180 min after each test meal (breakfast and lunch).
Immediately after consuming each of the two test meals, the subjects will take 1,500mg paracetamol to determine ventricular emptying rate using the acetaminophen test. After this, the subjects can lay in the bed and watch TV, iPad, or work on their laptop.
Before and every hour after consumption of the test meals, the subjects will be asked to fill out an appetite questionnaire (visual analogue scale). At the end of the day the participants will be offered an "ad libitum meal" to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.
An one-way mixed model of linear regression will be used to compare postprandial area under the curve, ventricular emptying, and ad libitum food intake between the three test days. Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements.
Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides (20), the investigators will need 11 subjects to detect a 15% decrease in postprandial triglyceride AUC (α=0.05, β=0.80). To account for potential missing values, 12 subjects will be included in total.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, double-blinded, controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| High-fat meal with intact MFGM | Experimental | Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch. |
| High-fat meal with destroyed MFGM | Experimental | Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. |
| High-fat meal without MFGM | Experimental | Dietary Supplement: Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years
- Written and informed consent
- HbA1c < 48 mmol/l
Key exclusion criteria (7 listed)
- Medicine with an impact on blood glucose, lipid profile, or blood pressure and birth control pills
- BMI > 30kg/m2
- Affected screening blood sample as evaluated by the clinical responsible investigator
- Severe claustrophobia
- Lactose intolerance
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 |
|---|---|---|
| Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch.1) Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. | Dietary supplement | High-fat meal with intact MFGM |
| Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch.2) Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. | Dietary supplement | High-fat meal with destroyed MFGM |
| Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch.3) Sandwich with butter-like dairy product (40g milk fat) without MFGM. | Dietary supplement | High-fat meal without MFGM |
Primary outcome
Difference in postprandial triglycerides measured as area under the curve (AUC).
Time frame: -60 to 180 minutes after first intervention (first meal), 0-180 minuter after second intervention (second high-fat meal)
Difference in triglycerides AUC after the intervention between high-fat meal with intact MFGM, high-fat meal with destroyed MFGM, and high-fat meal without MFGM.
21 secondary outcomes
Difference in concentration of GLP-1
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of Ghrelin
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of LEAP2
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of FFA
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of Insulin
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of glucagon
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of cholesterol (total, LDL and HDL)
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of GIP
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of CCK
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of Gastrin
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of GDF15
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein)
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration concentration of Cytokines
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of apoB48
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in concentration of apoB100
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in glucose concentration
Time frame: -60 to 360 minutes after first intervention (first high-fat meal)
Difference in appetite sensation
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Difference in gastric emptying rate
Time frame: -60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal)
Ad libitum meal test
Time frame: 420 minutes after start of test day.
Metabolic rate
Time frame: 0-420 minutes
Substrate metabolism
Time frame: 0-420 minutes
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 6 Mar 2025.
- Derived from this study: PubMed 42251897Voigt JH, Zubanovic NB, Moller AB, Suwal SK, Andersen U, Andersen HJ, Rittig N, Sondergaard E. Milk Fat Globule Membrane in a Novel High-Fat Spread Does Not Acutely Affect Postprandial Lipidemia in Healthy Individuals-A Randomized, Double-Blind Crossover Trial. J Nutr. 2026 Aug;156(8):101647. doi: 10.1016/j.tjnut.2026.101647. Epub 2026 Jun 6.
- Individual participant dataSharing planned: No
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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.
Esben Søndergaard, MD, PhD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch., Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. and Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. in people with Postprandial Lipid Metabolism, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 7 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 6 Mar 2025. 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 Denmark. 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?
Difference in postprandial triglycerides measured as area under the curve (AUC). (time frame: -60 to 180 minutes after first intervention (first meal), 0-180 minuter after second intervention (second high-fat meal)). 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 NCT06340412, 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 6 Mar 2025.