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

Launched by LOUGHBOROUGH UNIVERSITY · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special kind of milk fat, which is enriched with whey protein, affects heart and brain health after eating a high-fat meal. The study involves postmenopausal women aged 50 to 70 who are living with overweight and have a moderate risk for heart disease. Participants will take part in two study visits where they will eat a high-fat meal containing either the whey protein-enriched ingredient or a placebo (a similar product without the special ingredient). During these visits, researchers will measure heart health through blood pressure and blood tests, as well as assess brain function and mood with computer-based tests.

To be eligible for the study, participants must be healthy postmenopausal women, have a body mass index (BMI) between 25 and 40, and be physically active. They should not have any serious medical conditions that could affect the study results, like cardiovascular diseases or significant mental health issues. Participants will need to commit to following the study procedures, including eating the meals provided. This trial is not yet recruiting participants, so if you or someone you know is interested, keep an eye out for updates!

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Apparently healthy postmenopausal women (not menstruating for 12 or more months)
• • Aged 50 - 70 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)