Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT06953232
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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT06953232
Study Brief:
Protocol Section:
NCT06953232