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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT07182292
Eligibility Criteria:
Inclusion Criteria:
* Patient aged ≥ 75 years.
* Diagnosis of frailty according to Linda Fried's criteria.
* Diagnosis of malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria.
* Barthel Index score ≥ 60 points.
* Absence of advanced chronic kidney disease (defined as glomerular filtration rate \< 25 mL/min/1.73m²).
* Absence of terminal illness as defined by SECPAL (Spanish Society for Palliative Care) criteria.
Exclusion Criteria:
* Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1c \> 8% or insulin-dependent).
* Oropharyngeal dysphagia to liquids that prevents safe intake of oral supplementation.
* Moderate-to-severe cognitive impairment, defined as a score ≥ 5 on the Global Deterioration Scale (GDS) of Reisberg.
* Refusal to sign the informed consent by the patient, primary caregiver, or legal representative, or inability to obtain it.
* Known allergy or intolerance to any component of the study supplements.
* Institutionalized in a long-term care or residential facility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT07182292
Study Brief:
Protocol Section:
NCT07182292