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Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

NCT ID: NCT05066503

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subacute Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Delirious subjects receiving active study product

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

Group Type ACTIVE_COMPARATOR

260279 active study product

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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there is not a non-proprietary name for this supplement.

Eligibility Criteria

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Inclusion Criteria

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


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

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gohar Azhar, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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UAMS Center on Aging

Little Rock, Arkansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gohar Azhar, M.D.

Role: CONTACT

Phone: 5015265935

Email: [email protected]

Facility Contacts

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Reino Henderson, PA

Role: primary

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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260279

Identifier Type: -

Identifier Source: org_study_id