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The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.
This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 40 delirious and 20 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (60 subjects maximum). Twenty patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 20 patients with delirium will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delirious subjects receiving active study product | Active Comparator | Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days. |
|
| Control group | No Intervention | Delirious control group and non-delirious control group who receives standard treatment in the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 260279 active study product | Dietary Supplement | The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4. | CAM-S and 4 AT is a tool to determine and quantify delirium. Subjects in the non-control arms will undergo this test twice each day. The score ranges from 0-7, with lower numbers being better (little to no signs of delirium). | As determined over an up to 4-day intervention duration. |
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Inclusion Criteria: Delirious cohort
Aged 60 years and older.
Documented presence of either delirium, acute confusion, or altered mental status in medical record.
Currently hospitalized with a diagnosis of one of the following:
Inclusion Criteria: NON-Delirious cohort
Aged 60 years and older.
Current diagnosis of one of the following:
Exclusion Criteria: all subjects
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gohar Azhar, M.D. | Contact | 5015265935 | azhargohar@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gohar Azhar, M.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Center on Aging | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |