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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Loughborough University
  Loughborough, Leicestershire, United Kingdom Recruiting

Study contacts

• Study coordinator: Oonagh Markey, BSc, PhD
• Email: o.markey@lboro.ac.uk
• Phone: +44 1509 222737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.