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Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Sponsor
University of Arkansas (Other)
Overall Status
Suspended
CT.gov ID
NCT05066503
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
27.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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 people 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 1 week, and 15 will drink a placebo (sugar water) for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: 260279 active study product
  • Dietary Supplement: 260279 placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Actual Study Start Date :
Nov 16, 2020
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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 7 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.

    		•
    Placebo Comparator: Delirious subjects receiving placebo

    Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 7 days.

    Dietary Supplement: 260279 placebo
    A drink made of flavored, sweetened water.
    No Intervention: Non-delirious control subjects who receive no intervention

    Subjects receive no intervention and are observed for 2-3 days.

    Outcome Measures

    Primary Outcome Measures

    1. Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 7. [As determined over an up to 7-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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Delirious cohort

    1. Aged 65 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:

    4. sepsis/septicemia

    5. Pneumonia

    6. Urinary tract infection

    7. Clostridium-difficile infection

    Inclusion Criteria: NON-Delirious cohort

    1. Aged 65 years and older.

    2. Current diagnosis of one of the following:

    3. sepsis/septicemia

    4. Pneumonia

    5. Urinary tract infection

    6. Clostridium-difficile infection

    Exclusion Criteria: all subjects

    1. Chronic kidney disease (eGFR <30).

    2. History of Parkinson's disease.

    3. History of a major psychiatric illness.

    4. Delirium etiology of drug overdose or alcohol withdrawal.

    5. Current hyponatremia.

    6. Currently on sedative/hypnotic medications and not expected to stop.

    7. Major surgery within the past two weeks.

    8. Known or suspected Covid-19 positive.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAMS Center on Aging Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT05066503
    Other Study ID Numbers:
    • 260279
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Aug 11, 2022