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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT04858932
Eligibility Criteria:
Inclusion Criteria:
\[separated into the three groups based on the Fried Criteria: 0, 1-2, 3 or above\]
* Male or female participants aged 65 - 85 years.
* No clinically significant health problems other than well controlled chronic conditions (e.g., allergies and dermatitis)
* No recent hospitalizations/acute events in last 12 months.
* No active or recent (within 12 months) cancer diagnosis except skin cancer (limited to only non-complicated Squamous Cell Carcinoma (SCC)/Basal Cell Carcinoma (BCC)).
* Body mass index (BMI) \< 30 kg/m2
* Able to understand and cooperate with study procedures and able to read, understand and provide informed consent. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
* Participants should not have any food aversion which could influence their food selection if standardized meals are used as part of the protocol.
* Native English speakers or demonstrated fluency in English as determined by the Investigator.
* Wide Range Achievement Test (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater.
* Normal or corrected-to-normal vision
Exclusion Criteria:
* Treatment with an investigational drug within 30 days of enrollment
* A moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
* Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Boston University/Boston Medical Center directly involved in the conduct of the study
* Inability to comply with study requirements.
* Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes subject's participation in study activities including any self-reported diagnosis of eating disorders.
* Participants with electronic implant devices, such as pacemaker.
* Non-English Reader as measured by the WRAT-4.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT04858932
Study Brief:
Protocol Section:
NCT04858932