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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06593769
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 45 - 70 years, at enrolment.
2. Body mass index (BMI) ≥ 27 kg/m² but \< 35 kg/m².
3. Healthy participants based on medical history.
4. Able to understand and to sign a written informed consent prior to study enrolment.
5. Willing and able to comply with the requirements for participation in this study.
Exclusion Criteria:
1. Any past or on-going diagnosed medical/surgical condition (i.e., diabetes, malignancy, gastrointestinal disease, chronic inflammatory condition, chronic kidney disease, cardiovascular disease, bleeding disorder) and/ or psychiatric condition (e.g. depression, psychotic disorders, chronic insomnia, eating disorder), which in the opinion of the site physician/investigator may risk participant's well-being/safety, impede participant compliance with study procedures or ability to complete the study and/or could confound the primary objectives of the study.
2. Random plasma glucose ≥ 11.1 mmol/L or fasting plasma glucose ≥ 7.0 mmol/L (finger-prick point-of-care \[POC\] testing)
3. HbA1c ≥ 6.5% (finger-prick POC testing)
4. Known inborn errors of amino acid and protein metabolism.
5. With planned/scheduled medical imaging procedure/s (magnetic resonance imaging \[MRI\], computed tomography \[CT\] scan, X-ray), or electrical heat (diathermy) treatment during the study period.
6. Known or suspected allergies or intolerances to any of the ingredients of the nutritional formulation (i.e., milk, lactose) and the study meals.
7. Known or suspected cutaneous hypersensitivity to adhesives, silicon, or plaster.
8. Substantial changes in eating habits (i.e., switching from one dietary regimen to another) up to 30 days before enrolment.
9. Anticipated change in usual physical activity levels during the study period (e.g., plans for undertaking new vigorous-intensity physical activity such as: jogging, running, carrying heavy objects or other loads upstairs, shoveling snow, participating in a fitness class, and fast swimming, that will lead to hard and fast breathing).
10. Any chronic alcohol or drug abuse within the past year; specifically, alcohol intake \> 2 servings per day for males and \>1 serving per day for females. A serving corresponds to 0.35dl of liquor/strong alcohol, 1 dl of wine, or 3 dl of beer.
11. Female participants who are pregnant, lactating and/or breastfeeding.
12. Participants who refuse to be informed of incidental findings relevant to their health (e.g. abnormal laboratory results).
13. Currently participating in another interventional study.
14. Family or hierarchical relationships with the research team members.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT06593769
Study Brief:
Protocol Section:
NCT06593769