Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Study Overview
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Brief Summary
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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 people who are hospitalized for certain infections. In this study, up to 45 people will be enrolled. 15 will be asked to drink this blend twice a day for up to 4 days, and 15 will drink a placebo (sugar water) for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products.

Detailed Description
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This will be a controlled, randomized 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 at hospitalized UAMS for certain infections. Up to 30 delirious and 15 non-delirious subjects of any gender or ethnicity will be enrolled (45 subjects maximum). 15 will be asked to drink this blend twice a day for up to 4 days, and 15 will drink a placebo (sugar water) for the same time period. The other 15 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.

Official Title
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Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Conditions
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Subacute Delirium

Intervention / Treatment
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* Dietary Supplement: 260279 active study product
* Dietary Supplement: 260279 placebo


Participation Criteria
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Eligibility Criteria
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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: sepsis/septicemia Pneumonia Urinary tract infection Clostridium-difficile infection Other bone or tissue infection Fever of unknown origin Inclusion Criteria: NON-Delirious cohort Aged 60 years and older. Current diagnosis of one of the following: sepsis/septicemia Pneumonia Urinary tract infection Clostridium-difficile infection Other bone or tissue infection Fever of unknown origin Exclusion Criteria: all subjects Chronic kidney disease (eGFR <30). Admitted to the hospital for major psychiatric illness. Major psychiatric illness not controlled by medication/treatment. Delirium etiology of drug overdose or alcohol withdrawal. Major surgery within the past five days. Known or suspected Covid-19 positive. Continuous feeding tube

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delirious subjects receiving active study product<br>Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days. | Dietary Supplement: 260279 active study product<br>* The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.<br>* Other names: there is not a non-proprietary name for this supplement.;|
| Placebo Comparator: Delirious subjects receiving placebo<br>Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days. | Dietary Supplement: 260279 placebo<br>* A drink made of flavored, sweetened water.<br>|
| No Intervention: Non-delirious control subjects who receive no intervention<br>Subjects receive no intervention and are observed for 2-3 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4. | CAM-S 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. |