Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

University of Arkansas

Status: Enrolling

Conditions: Subacute Delirium

Treatments: Dietary Supplement: 260279 active study product

Study type: Interventional

Funder types: Other

Identifiers

NCT05066503

260279

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Delirious cohort

1. Aged 60 years and older.

2. Documented presence of either delirium, acute confusion, or altered mental status in medical record.

3. Currently hospitalized with a diagnosis of one of the following:

   1. sepsis/septicemia
   2. Pneumonia
   3. Urinary tract infection
   4. Clostridium-difficile infection
   5. Other bone or tissue infection
   6. Fever of unknown origin

Inclusion Criteria: NON-Delirious cohort

1. Aged 60 years and older.

2. Current diagnosis of one of the following:

   1. sepsis/septicemia
   2. Pneumonia
   3. Urinary tract infection
   4. Clostridium-difficile infection
   5. Other bone or tissue infection
   6. Fever of unknown origin

Exclusion Criteria: all subjects

1. Chronic kidney disease (eGFR <30).
2. Admitted to the hospital for major psychiatric illness.
3. Major psychiatric illness not controlled by medication/treatment.
4. Delirium etiology of drug overdose or alcohol withdrawal.
5. Major surgery within the past five days.
6. Known or suspected Covid-19 positive.
7. Continuous feeding tube

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Delirious subjects receiving active study product

Active Comparator group

Description:

Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.

Treatment:

Dietary Supplement: 260279 active study product

Control group

No Intervention group

Description:

Delirious control group and non-delirious control group who receives standard treatment in the hospital.