An interventional study of Whey protein-enriched milk fat globule membrane supplement and Whey protein-based supplement in Cardiovascular Diseases, Cognition and Overweight or Obesity, sponsored by Loughborough University. Recruiting at 1 site in United Kingdom. Open to female participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Loughborough University · Not applicable, Interventional, and Prevention
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 16 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Loughborough University is the lead sponsor of 76 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Whey protein-enriched milk fat globule membrane supplement
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.
Dietary Supplement: Whey protein-based 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.
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.
Also known as: Placebo
Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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 AUC₀-₃₆₀min.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Assessed using high-throughput 1H-NMR metabolomics platform.
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.
Assessed using high-throughput 1H-NMR metabolomics platform.
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.
Assessed using high-throughput 1H-NMR metabolomics platform.
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.
Assessed using high-throughput 1H-NMR metabolomics platform.
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.
Assessed using high-throughput 1H-NMR metabolomics platform.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Determined by ELISA.
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by ELISA
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.
Determined by automated upper arm sphygmomanometer
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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
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 biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via iAUC₀-₃₆₀min.
Determined by ELISA
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 biomarkers of cognitive health/neuroinflammation (for example, brain-derived neurotrophic factor), assessed via time-course profiles.
Determined by ELISA
Time frame: Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Oct 2026, 13 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 13 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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Loughborough University