Cardiovascular DiseasesNCT06953232
Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health
A study testing Whey protein-enriched milk fat globule membrane supplement and Whey protein-based supplement in people with Cardiovascular Diseases and Cognition, run by Loughborough University at 1 site in United Kingdom.
Trial summary
In a single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal… Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cognition, Overweight or Obesity
- What is being tested?
- Whey protein-enriched milk fat globule membrane supplement and Whey protein-based supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy postmenopausal women (not menstruating for 12 or more months)
- Aged 50 - 75 years
- BMI: 25 - 40 kg/m²
- Moderate CVD risk
- Recreationally active (> 3 x 30 min moderate exercise per week)
- Understands and is willing and able to comply with all study procedures including eating a high-fat breakfast meal
- Fluent in written and spoken English
- Access to, and able to use, the internet/computer/tablet device
Who cannot join
- Smoking (including vaping)
- 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 e.g., diabetes, digestive, cancer or thyroidal disease, neurological disease (Alzheimer's disease, other form of dementia, mild cognitive impairment), or serious mental illness know to affect cognition (schizophrenia, schizoaffective disorder, bipolar disorder), learning disorders (dyslexia)
- Early or premature menopause resulting from medical conditions or undergoing surgery
- Hormone replacement therapy within last 6 months
- Prescribed medications likely to interfere with study outcomes (including lipid/cholesterol-lowering medications, including statins; blood thinners, antiplatelets (anticoagulants) such as heparin, etc.; medications for blood pressure; inflammation such as nonsteroidal anti-inflammatory drugs, aspirin, etc.; immune function, or lipid/carbohydrate metabolism) or prescribed antibiotics within the last three months
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- Use of antidepressant or anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period
- Taking vitamin, mineral, or fatty acid supplements (e.g., fish oil, calcium) or unwilling stop consuming these for the duration of the study (including sufficient washout period)
- Working night shifts
- Inaccessible veins for blood collection via cannulation
- Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
- Known allergy or intolerance to study food (including lactose intolerance, dairy, and wheat)
- 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 (i.e., more than 10 and a half pints of beer or 21 small glasses of wine)
- Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aishwarya Borkar, BSc, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Loughborough University
Loughborough, Leicestershire, LE11 3TU
Oonagh Markey, o.markey@lboro.ac.uk
About this study
Official title: Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health in Postmenopausal Women Living With Overweight and at Moderate Risk for Cardiovascular Disease.
In a single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease.
Participants will attend two ~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.
- Conditions
- Cardiovascular Diseases, Cognition, Overweight or Obesity, Postmenopausal Women, Cardiometabolic Risk Factors
- Being tested
- Whey protein-enriched milk fat globule membrane supplement, Whey protein-based supplement
- Keywords
- Milk fat globule membrane, Milk polar lipids, triacylglycerol, postprandial, cholesterol, cardiometabolic disease risk, cognitive function
- 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.
Whey protein-enriched milk fat globule membrane supplementDietary supplement
Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil), supplemented with a whey protein-enriched milk fat globule membrane (providing ~5 g of milk polar lipids) powdered ingredient. The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions.
Whey protein-based supplementDietary supplement
Also called Placebo
Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil) supplemented with a whey protein-based powdered ingredient without milk fat globule membrane (placebo) The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein-enriched milk fat globule membrane supplement | Experimental | Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil), supplemented with a whey protein-enriched milk fat globule membrane (providing ~5 g of milk polar lipids) powdered ingredient. The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. Receives: Dietary Supplement: Whey protein-enriched milk fat globule membrane supplement |
| Whey protein-based supplement | Placebo comparator | Participants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil) supplemented with a whey protein-based powdered ingredient without milk fat globule membrane (placebo) The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. Receives: Dietary Supplement: Whey protein-based supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Secondary outcomes (50)
Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via Cₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via Tₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via time-course profile.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via AUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via iAUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via Cₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via Tₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via time-course profiles.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via AUC₀-₃₆₀min.
Assessed using high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via iAUC₀-₃₆₀min.
Assessed using high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Cₘₐₓ.
Assessed using high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Tₘₐₓ.
Assessed using high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via time-course profiles.
Assessed using high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via AUC₀-₃₆₀min.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via iAUC₀-₃₆₀min.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via time-course profile.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via AUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via iAUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via Cₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via Tₘₐₓ.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via timecourse profile.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via AUC₀-₃₆₀min.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via iAUC₀-₃₆₀min.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via Cₘₐₓ.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via Tₘₐₓ.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via timecourse profile.
Determined by ELISA.
Measured: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via AUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via iAUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via time-course profile.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via AUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via iAUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via time-course profile.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via AUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via iAUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via time-course profile.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via AUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via iAUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via time-course profiles.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in clinic systolic and diastolic blood pressure, assessed via AUC₀-₃₆₀min.
Determined by automated upper arm sphygmomanometer
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in clinic systolic and diastolic blood pressure, assessed via iAUC₀-₃₆₀min.
Determined by automated upper arm sphygmomanometer
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in clinic systolic and diastolic blood pressure, assessed via time-course profiles.
Determined by automated upper arm sphygmomanometer
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via AUC₀-₃₆₀min.
Determined by radial pulse wave analysis (using applanation tonometry)
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via iAUC₀-₃₆₀min.
Determined by radial pulse wave analysis (using applanation tonometry)
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in markers of arterial stiffness including augmentation index and augmentation index adjusted to a standard heart rate of 75 bpm, assessed via time-course profiles.
Determined by radial pulse wave analysis (using applanation tonometry)
Measured: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in cognitive test performance.
Cognition will be assessed using a neuropsychological nine-test battery which assesses global and domain-specific function, as determined by NeurOn software.
Measured: Test battery will be completed at 0 (baseline) and 240 minutes (after meal ingestion)
Postprandial change in mood.
Determined by the Bond-Lader visual analogue scale (includes 16 items each having antonyms on two ends, on a scale of 1 to 100, 50 being the neutral point)
Measured: Questionnaire will be completed at 0 (baseline) and 240 minutes (after meal ingestion)
Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via AUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via iAUC₀-₃₆₀min.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via time-course profiles.
Determined by ELISA
Measured: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start30 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
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
- NCT06953232
- Sponsor's protocol ID
- Project ID: 18721
- Status last verified
- May 2026
- First submitted
- 15 Apr 2025
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health in Postmenopausal Women Living With Overweight and at Moderate Risk for Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT06953232
- Acronym / sponsor ID
- Project ID: 18721
- Conditions
- Cardiovascular Diseases, Cognition, Overweight or Obesity, Postmenopausal Women, Cardiometabolic Risk Factors
- Keywords
- Milk fat globule membrane, Milk polar lipids, triacylglycerol, postprandial, cholesterol, cardiometabolic disease risk, cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 May 2025 (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 single-blind, randomised, placebo-controlled crossover manner, this study aims to assess the impact of a high-fat mixed meal containing a whey protein (WP)-enriched milk fat globule membrane (MFGM) powdered ingredient on markers of heart and brain health in the fed state among middle-to-older-aged, postmenopausal women living with overweight and at moderate risk for cardiovascular disease.
Participants will attend two ~8 hour study visits, where they will consume a high-fat meal containing a WP-enriched MFGM powdered ingredient or a placebo WP-based powdered ingredient. Each visit will involve anthropometric measurements and periodic assessments of heart health, including blood pressure and blood vessel stiffness measurements, blood sample collections, as well as computer-based tests measuring mood and cognition (brain function) over a 6-hour postprandial period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein-enriched milk fat globule membrane supplement | Experimental | Dietary Supplement: Whey protein-enriched milk fat globule membrane supplementParticipants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil), supplemented with a whey protein-enriched milk fat globule membrane (providing ~5 g of milk polar lipids) powdered ingredient. The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. |
| Whey protein-based supplement | Placebo comparator | Dietary Supplement: Whey protein-based supplementParticipants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil) supplemented with a whey protein-based powdered ingredient without milk fat globule membrane (placebo) The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Apparently healthy postmenopausal women (not menstruating for 12 or more months)
- Aged 50 - 75 years
- BMI: 25 - 40 kg/m²
- Moderate CVD risk
- Recreationally active (> 3 x 30 min moderate exercise per week)
Key exclusion criteria (15 listed)
- Smoking (including vaping)
- 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 e.g., diabetes, digestive, cancer or thyroidal disease, neurological disease (Alzheimer's disease, other form of dementia, mild cognitive impairment), or serious mental illness know to affect cognition (schizophrenia, schizoaffective disorder, bipolar disorder), learning disorders (dyslexia)
- Early or premature menopause resulting from medical conditions or undergoing surgery
- Hormone replacement therapy within last 6 months
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 |
|---|---|---|
| Whey protein-enriched milk fat globule membrane supplementParticipants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil), supplemented with a whey protein-enriched milk fat globule membrane (providing ~5 g of milk polar lipids) powdered ingredient. The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. | Dietary supplement | Whey protein-enriched milk fat globule membrane supplement |
| Whey protein-based supplementAlso: PlaceboParticipants will consume a high-fat, mixed meal containing approximately 75 g of test fat (refined palm oil) supplemented with a whey protein-based powdered ingredient without milk fat globule membrane (placebo) The experimental and placebo meals will be isoenergetic and protein-matched, and will be administered in a randomised order, with a washout period of at least 21 days between sessions. | Dietary supplement | Whey protein-based supplement |
Primary outcome
Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
50 secondary outcomes
Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via Cₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via Tₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating triacylglycerol response, assessed via time-course profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via Cₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via Tₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating lipid and apolipoprotein responses, assessed via time-course profiles.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Cₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via Tₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial changes in circulating lipoprotein subclass particle size and concentrations, assessed via time-course profiles.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating apolipoprotein B48 response, assessed via time-course profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via Cₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via Tₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating glucose response, assessed via timecourse profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via Cₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via Tₘₐₓ.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating insulin response, assessed via timecourse profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating interleukin-6 response, assessed via time-course profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating soluble CD14 response, assessed via time-course profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in circulating lipopolysaccharide-binding protein response, assessed via time-course profile.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via AUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via iAUC₀-₃₆₀min.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in responses of selected circulating gut-related metabolite (for example, trimethylamine N-oxide, and short-chain fatty acids), assessed via time-course profiles.
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Postprandial change in clinic systolic and diastolic blood pressure, assessed via AUC₀-₃₆₀min.
Time frame: Measurements will be taken at 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- 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.
Aishwarya Borkar, BSc, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein-enriched milk fat globule membrane supplement and Whey protein-based supplement in people with Cardiovascular Diseases and Cognition, 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 8 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oonagh Markey, BSc, PhD (+44 1509 222737, o.markey@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min. (time frame: Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)). 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 20 May 2026.