Whey protein–enriched milk fat globule membrane added to a high‑fat meal to see short‑term heart and brain effects in postmenopausal women

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.

This trial will test whether adding a whey protein–enriched milk fat globule membrane powder to a high‑fat meal changes short‑term heart and brain health markers in postmenopausal women with overweight and moderate cardiovascular risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 50 Years to 75 Years
• Sex: Female
• Sponsor: Loughborough University (other)
• Locations: 1 site (Loughborough, Leicestershire)
• Trial ID: NCT06953232 on ClinicalTrials.gov

What this trial studies

In a single‑blind, randomized, placebo‑controlled crossover design, participants attend two ~8‑hour visits and consume a high‑fat meal containing either a whey protein‑enriched milk fat globule membrane (MFGM) powder or a placebo whey protein powder. Each visit includes repeated measurements over a 6‑hour postprandial period, including blood pressure, vascular stiffness, blood draws for biochemical markers, and computer‑based mood and cognitive tests. The study enrolls middle‑to‑older‑aged postmenopausal women with overweight and moderate cardiovascular risk and compares within‑person responses to the two meal conditions. Results will focus on acute post‑meal changes in cardiometabolic and cognitive markers.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 50–75 with BMI 25–40 kg/m² who have moderate cardiovascular risk, are recreationally active, and can attend two full‑day visits at the study site.

Not a fit: People who smoke or have diagnosed cardiovascular disease, recent heart attack or stroke, diabetes, major neurological or gastrointestinal disease, or other excluded medical conditions are unlikely to benefit from or qualify for this trial.

Why it matters

Potential benefit: If successful, this could point to a simple meal supplement that improves short‑term vascular, lipid, or cognitive responses after eating, which might help reduce cardiometabolic risk over time.

How similar studies have performed: Previous short‑term trials of milk polar lipids and MFGM have shown modest effects on blood lipids and some cognitive markers, but results are limited and this specific whey protein–enriched MFGM approach is relatively novel.

Eligibility 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 this trial is running

Loughborough, Leicestershire

• Loughborough University — Loughborough, Leicestershire, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Oonagh Markey, BSc, PhD

Conditions: Cardiovascular Diseases, Cognition, Overweight or Obesity, Postmenopausal Women, Cardiometabolic Risk Factors, Milk fat globule membrane, Milk polar lipids, triacylglycerol