Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 260279 active study product.
- Who it may be relevant to
- Registry conditions: Subacute Delirium. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UAMS Center on Aging — Little Rock
Identifiers
NCT: NCT05066503 · 260279