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

Sponsor: Loughborough University

NCT ID: NCT06953232

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Whey protein-enriched milk fat globule membrane supplement (supplement), Whey protein-based supplement (supplement)
How long the study runs
Study runs about 13 months (dates as stated)
About the drug or intervention
Whey protein-enriched milk fat globule membrane supplement — 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. · Whey protein-based supplement — 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 75 Years
Who
Female
Number of participants
16
Started
2025-09-30
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiovascular diseases
  • • NA - 16 participants
  • • 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

Who can take part?

  • • Ages 50 Years to 75 Years
  • • Diagnosed with cardiovascular diseases
  • • Female only

Where?

  • • Loughborough - Loughborough University

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Cardiovascular DiseasesCognitionOverweight or ObesityPostmenopausal WomenCardiometabolic Risk Factors

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 75 Years
  • Who can join: Female only

What the study is looking for

  • ✓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)

Who cannot take part

  • ✗Smoking (including vaping)
  • ✗Diagnosed with cardiovascular disease or suffered myocardial infarction /stroke in the past twelve months
  • ✗Early or premature menopause resulting from medical conditions or undergoing surgery
  • ✗Hormone replacement therapy within last 6 months
  • ✗Use of antidepressant or anti-anxiety medication if it has changed in the last three months or expected to change...
See the full criteria
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)

Where Is This Study? (1 UK site)

Loughborough University

Loughborough LE11 3TU, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Oonagh Markey, BSc, PhD

Sponsor contact

CONTACT

+44 1509 222737 o.markey@lboro.ac.uk

Aishwarya Borkar, BSc, MSc

Sponsor contact

CONTACT

a.s.borkar@lboro.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05