NCT06953232Recruiting
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.
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 15 Apr 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Loughborough University
- Diseases
- Obesity
- NCT number
- NCT06953232
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 30 Sept 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
- Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
Other illness
- 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
- Known allergy or intolerance to study food (including lactose intolerance, dairy, and wheat)
Lab values
- 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)
Other
- Smoking (including vaping)
- Working night shifts
- Inaccessible veins for blood collection via cannulation
- 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)
Who 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)
- 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
Age in the registry: 50 years to 75 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loughborough University Coordinator of this site? Confirm its status | Loughborough | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.