Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Overweight or Obesity; Cognition; Postmenopausal Women; Cardiometabolic Risk Factors
• Intervention / Treatment: Dietary supplement: Whey protein-enriched milk fat globule membrane supplement; Dietary supplement: Whey protein-based supplement

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oonagh Markey, BSc, PhD; Phone Number: +44 1509 222737; Email: o.markey@lboro.ac.uk
• Study Contact Backup: Name: Aishwarya Borkar, BSc, MSc; Email: a.s.borkar@lboro.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE11 3TU
      • Recruiting
      • Loughborough University
      • Contact: Oonagh Markey; Email: o.markey@lboro.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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-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-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.
Placebo Comparator: 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-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-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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial change in circulating triacylglycerol response, assessed by iAUC 0-360 min.	Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.	Blood samples will be taken at -60, 0 (baseline) and 30, 60, 90, 120, 180, 240, 300, 360 minutes (after meal ingestion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial change in circulating triacylglycerol response, assessed via AUC₀-₃₆₀min.	Measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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)	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)	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.	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)	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	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	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	Blood samples will be taken at -60, 0 (baseline) and 120, 240, 360 minutes (after meal ingestion)

Collaborators and Investigators

• Sponsor: Loughborough University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cognitive function; postprandial; cholesterol; cardiometabolic disease risk; triacylglycerol; Milk fat globule membrane; Milk polar lipids
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Cardiovascular Diseases; Anti-Infective Agents; Milk fat globule
• Other Study ID Numbers: Project ID: 18721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No