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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04713735
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 55 years of age at time of consent
* Able to eat and drink, with assistance if required
* Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study
* Signed consent obtained from subject or legally authorized representative
* Signed authorization obtained to use and/or disclose Protected Health Information
Exclusion Criteria:
* Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition
* Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation
* Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject
* Known allergy or intolerance to study products
* On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months
* Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration
* Have experienced Respiratory Tract Infection within 1 week prior to randomization
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT04713735
Study Brief:
Protocol Section:
NCT04713735