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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT07254403
Eligibility Criteria:
Inclusion criteria:
* Age 65-95 years old
* Ability to walk, sit down, and stand up (independently or with walking assistance device)
* No recent use (\< 4 weeks prior to start of the study) of dietary supplements and medication influencing protein and amino acid metabolism (e.g., antibiotics, oral corticosteroids)
* Willingness to lay supine in bed for up to 6 hours
* Willingness and ability to comply with the protocol
Exclusion criteria
* Presence of malnutrition (BMI \< 17 kg/m2), 2). BMI \>35 kg/m2 to avoid weight-related metabolic disturbances,
* Established diagnosis and active treatment of chronic disease: Insulin-dependent diabetes mellitus, active malignancy, heart disease, kidney disease, liver disease, HIV/AIDS, Asthma (moderate to severe), Hep (A, B, or C)
* History of untreated metabolic disease including hepatic or renal disorder
* Presence of fever within the last 3 days
* Cirrhosis of liver
* Diagnosis of dementia, neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia).
* (Possible) pregnancy
* Presence of acute illness or metabolically unstable chronic illness
* Active dependence on alcohol or drugs
* Newly prescribed long-term oral corticosteroids
* Planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject
* Already enrolled in another clinical trial
* Any condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
* Known allergy to any of the components of the feeding (soy, beef)
* Established daily diet of vegetarian/vegan composition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
95 Years
Study:
NCT07254403
Study Brief:
Protocol Section:
NCT07254403