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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT03766620
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study
* Considered malnourished, or at risk for malnutrition
* Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin
* Conforms to the requirements set forth on the study product label
* Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional
* Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay \> 3 days and \< 12 days
Exclusion Criteria:
* Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product
* Renal or liver failure
* Participates in another study that has not been approved as a concomitant study by AN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03766620
Study Brief:
Protocol Section:
NCT03766620