Cardiovascular DiseasesNCT05939544
Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health
A study testing Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient in people with Cardiovascular Diseases and Overweight and Obesity, run by Loughborough University at 1 site in United Kingdom.
Trial summary
In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Overweight and Obesity, Cognition
- What is being tested?
- Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2023to 24 Sep 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40 - 70 years
- BMI: 25-45 kg/m2
- Recreationally active (> 3 x 30 min moderate exercise per week)
- Understands and is willing and able to comply with all study procedures, including changes to diet
- Fluent in written and spoken English
- Access to, and able to use, the internet/computer/tablet device
Who cannot join
- Smoking (including vaping)
- Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
- Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
- Diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months
- Existing or significant past medical history of any medical condition likely to affect the study outcomes.
- Prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months
Show all 11Show fewer
- Use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period.
- Known allergy or intolerance to study food (lactose intolerance, dairy)
- Being vegan or any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
- Excessive alcohol consumption: >21 unit/wk
- Pregnancy, seeking to become pregnant or active lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.
- Conditions
- Cardiovascular Diseases, Overweight and Obesity, Cognition
- Being tested
- Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient, Placebo Comparator: Control (Placebo) Powdered Ingredient
- Keywords
- milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk
- Medical subject headings
- Cardiovascular Diseases, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Milk Fat Globule Membrane-enriched Powdered IngredientDietary supplement
Milk Fat Globule Membrane-enriched Powdered Ingredient
Placebo Comparator: Control (Placebo) Powdered IngredientDietary supplement
Placebo Comparator: Control (Placebo) Powdered Ingredient
| Study group | Role | What they receive |
|---|---|---|
| Milk Fat Globule Membrane-enriched Powdered Ingredient | Experimental | Participants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding. Receives: Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient |
| Control (Placebo) Powdered Ingredient | Placebo comparator | Participants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding. Receives: Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered Ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change-from-baseline in circulating LDL-cholesterol concentrations
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Secondary outcomes (16)
Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in interleukin-6 concentrations (determined by ELISA)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in insulin concentrations (determined by ELISA)
Assessed following the collection of fasted blood samples before and after each 28-day study period
Measured: 28 days
Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])
Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period
Measured: 28 days
Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in cognitive test performance using a neuropsychological seven-test battery which assesses global and domain specific function, as determined by NeurOn software
Assessed before and after each 28-day study period
Measured: 28 days
Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in body mass (kg) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in waist circumference (cm) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Change-from-baseline in body fat (%) using standard equipment.
Assessed in the fasted state before and after each 28-day study period
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start10 Jul 2023
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oonagh Markey, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939544
- Sponsor's protocol ID
- 10260
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
- ClinicalTrials.gov ID
- NCT05939544
- Acronym / sponsor ID
- 10260
- Conditions
- Cardiovascular Diseases, Overweight and Obesity, Cognition
- Keywords
- milk fat globule membrane, milk polar lipids, cholesterol, cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 11 Jul 2023 (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.
In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Fat Globule Membrane-enriched Powdered Ingredient | Experimental | Dietary Supplement: Experimental: Milk Fat Globule Membrane-enriched Powdered IngredientParticipants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding. |
| Control (Placebo) Powdered Ingredient | Placebo comparator | Dietary Supplement: Placebo Comparator: Control (Placebo) Powdered IngredientParticipants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 40 - 70 years
- BMI: 25-45 kg/m2
- Recreationally active (> 3 x 30 min moderate exercise per week)
- Understands and is willing and able to comply with all study procedures, including changes to diet
- Fluent in written and spoken English
Key exclusion criteria (11 listed)
- Smoking (including vaping)
- Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
- Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
- Diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months
- Existing or significant past medical history of any medical condition likely to affect the study outcomes.
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 |
|---|---|---|
| Experimental: Milk Fat Globule Membrane-enriched Powdered IngredientMilk Fat Globule Membrane-enriched Powdered Ingredient | Dietary supplement | Milk Fat Globule Membrane-enriched Powdered Ingredient |
| Placebo Comparator: Control (Placebo) Powdered IngredientPlacebo Comparator: Control (Placebo) Powdered Ingredient | Dietary supplement | Control (Placebo) Powdered Ingredient |
Primary outcome
Change-from-baseline in circulating LDL-cholesterol concentrations
Time frame: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
16 secondary outcomes
Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)
Time frame: 28 days
Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform
Time frame: 28 days
Change-from-baseline in interleukin-6 concentrations (determined by ELISA)
Time frame: 28 days
Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)
Time frame: 28 days
Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)
Time frame: 28 days
Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)
Time frame: 28 days
Change-from-baseline in insulin concentrations (determined by ELISA)
Time frame: 28 days
Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])
Time frame: 28 days
Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)
Time frame: 28 days
Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)
Time frame: 28 days
Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)
Time frame: 28 days
Change-from-baseline in cognitive test performance using a neuropsychological seven-test battery which assesses global and domain specific function, as determined by NeurOn software
Time frame: 28 days
Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)
Time frame: 28 days
Change-from-baseline in body mass (kg) using standard equipment.
Time frame: 28 days
Change-from-baseline in waist circumference (cm) using standard equipment.
Time frame: 28 days
Change-from-baseline in body fat (%) using standard equipment.
Time frame: 28 days
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 16 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient in people with Cardiovascular Diseases and Overweight and Obesity, run by Loughborough University at 1 site in United Kingdom.
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 6 inclusion and 11 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 16 Oct 2024. 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 United Kingdom. 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?
Change-from-baseline in circulating LDL-cholesterol concentrations (time frame: 28 days). 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 16 Oct 2024.