Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age50 Years to 75 Years
SexFemale
Healthy volunteersAccepted
ConditionCardiovascular Diseases, Cognition, Overweight or Obesity, Postmenopausal Women, Cardiometabolic Risk Factors
Full registry 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)
Treatments and study arms
Whey protein-enriched milk fat globule membrane supplement
Dietary 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. 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.
Whey protein-based supplement
Dietary 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.
