💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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