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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01963767
Eligibility Criteria:
Inclusion Criteria:
* Adults 65-85 years of age (inclusive).
* Able to understand and sign the informed consent.
* Native English-speaking.
* No evidence of dementia (MMSE \>=23).
* Each subject must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
* All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice.
Exclusion Criteria:
* Use of high dose antioxidant supplements other than what is provided in the trial.
* History of known allergy to components of the study supplements.
* Mental illness judged by the PI to preclude a successful completion of the trial.
* Persons who are not native English speakers are excluded from the current proposal because many of the cognitive tests that are administered are language-based and are heavily influenced by first language.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT01963767
Study Brief:
Protocol Section:
NCT01963767