Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Not Applicable

Recruiting

• Conditions: Subacute Delirium
• Interventions: Dietary Supplement: 260279 active study product; Dietary Supplement: 260279 placebo

• Registration Number: NCT05066503
• Lead Sponsor: University of Arkansas

Brief Summary

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 45 people will be enrolled.15 will be asked to drink this blend twice a day for up to 4 days, and 15 will receive standard treatment in the hospital for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products.

Detailed 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 30 delirious and 15 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (45 subjects maximum). Fifteen patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 15 patients with delirium will receive standard treatment in the hospital 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.

Study Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-01
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delirious subjects receiving active study product	260279 active study product	Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
Delirious subjects receiving placebo	260279 placebo	Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days.

Primary Outcome Measures

Name	Time	Method
Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.	As determined over an up to 4-day intervention duration.	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).

Trial Locations

Locations (1)

UAMS Center on Aging; 🇺🇸 Little Rock, Arkansas, United States