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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05485402
Eligibility Criteria:
Inclusion Criteria:
* Men and women with and age equal to or greater than 60 years and until 80 years.
* Written informed consent provided before the initial visit.
* Sarcopenia assessment: low muscle strength based on grip dynamometry, kg (men \<30 kg; women \<20 kg) or low skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 (men \<8,87 kg/m2; women \<6,42 kg/m2) or low physical performance or physical function based on 4m gait speed, m/s (≤0,8 m/s)
Exclusion Criteria:
* Type 2 or insulin-dependent diabetes diagnosed.
* Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women).
* Intestinal malabsorption diseases.
* Fructose and/or sucrose intolerance.
* Malnutrition (assessed by albumin \<3,5 g/dl).
* Renal diseases.
* Chronic alcoholism.
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Institutionalized elderly.
* Failure to follow the study guidelines.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05485402
Study Brief:
Protocol Section:
NCT05485402