Recruiting

Nutritional Therapy

Sponsor:

University of Arkansas

Code:

NCT05066503

Conditions

Subacute Delirium

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

260279 active study product

Study Details

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 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.

Conditions

Subacute Delirium

Study ID

NCT05066503

Start date

Nov 16, 2020

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Delirious subjects receiving active study product

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

no intervention: Control group

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

Interventions

260279 active study product

The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.

Primary outcome measure

  • Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4. [ Time Frame: As determined over an up to 4-day intervention duration. ]

Central Contacts and Locations

Central contacts

Gohar Azhar, M.D.

5015265935azhargohar@uams.edu

Locations

UAMS Center on Aging

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Reino Henderson, PA

501-603-1514RAHenderson@uams.edu

Principal Investigator:

Gohar Azhar, M.D.

More Information

Sponsor

University of Arkansas

Last update posted

Jan 12, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-01-12.