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NCT Number: NCT05066503

Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Center on Aging

Little Rock, Arkansas, 72205, United States

Location status: Recruiting

Location contact

Archy Cui, M.D.

SUB_INVESTIGATOR

Chander Agarwal, M.D.

SUB_INVESTIGATOR

Elizabeth Eoff, M.D.

SUB_INVESTIGATOR

Gohar Azhar, M.D.

PRINCIPAL_INVESTIGATOR

Jeanne Wei, M.D.

SUB_INVESTIGATOR

Karen Coker, Ph.D.

SUB_INVESTIGATOR

Malodee Harris, D.N.P

SUB_INVESTIGATOR

Maneetha Kodali, M.D.

SUB_INVESTIGATOR

Navya Nalajala, M.D.

SUB_INVESTIGATOR

Obioma Nwaiwu, M.D.

SUB_INVESTIGATOR

Pankaj Patyal, Ph.D.

SUB_INVESTIGATOR

Regina Gibson, Ph.D.

SUB_INVESTIGATOR

Reino Henderson, PA

CONTACT

[email protected]

501-603-1514

Robert Wolfe, Ph.D.

SUB_INVESTIGATOR

Shakshi Sharma, Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

260279 active study product

Dietary Supplement

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gohar Azhar, M.D.

CONTACT

[email protected]

5015265935

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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