Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Conditions

• Subacute Delirium

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Nov 16, 2020

Status verified

Dec 2025

Primary completion

Aug 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• 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.
• No Intervention: Control group
  Delirious control group and non-delirious control group who receives standard treatment in the hospital.

Primary Outcome Measure

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. ]

Central Contacts

• Gohar Azhar, M.D.
  5015265935
  [email protected]

Locations (1)

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