Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

January 8, 2026 updated by: University of Arkansas
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • UAMS Center on Aging
        • Sub-Investigator:
          • Jeanne Wei, M.D.
        • Sub-Investigator:
          • Regina Gibson, Ph.D.
        • Contact:
        • Sub-Investigator:
          • Karen Coker, Ph.D.
        • Sub-Investigator:
          • Pankaj Patyal, Ph.D.
        • Sub-Investigator:
          • Robert Wolfe, Ph.D.
        • Principal Investigator:
          • Gohar Azhar, M.D.
        • Sub-Investigator:
          • Shakshi Sharma, Ph.D.
        • Sub-Investigator:
          • Elizabeth Eoff, M.D.
        • Sub-Investigator:
          • Maneetha Kodali, M.D.
        • Sub-Investigator:
          • Obioma Nwaiwu, M.D.
        • Sub-Investigator:
          • Chander Agarwal, M.D.
        • Sub-Investigator:
          • Archy Cui, M.D.
        • Sub-Investigator:
          • Navya Nalajala, M.D.
        • Sub-Investigator:
          • Malodee Harris, D.N.P

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: 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.
Other Names:
  • there is not a non-proprietary name for this supplement.
No Intervention: Control group
Delirious control group and non-delirious control group who receives standard treatment in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: As determined over an up to 4-day intervention duration.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Gohar Azhar, M.D., University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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