Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks

NCT ID: NCT05007730

Last Updated: 2025-12-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-11-03

Brief Summary

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Malnutrition significantly contributes to the disability and mortality associated with Alzheimer's disease and Alzheimer's disease-related dementias. Thus, nutritional status is one important, modifiable clinical factor for maintaining physical and cognitive health among persons with dementia (PWD). This project will pilot an innovative approach to enhancing nutrition through the use of transitional-state snack supplements, or foods that start as one texture and change to another.

Specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement among adults with dementia. The central hypothesis is that access to ready-made, savory, nutrient- dense snack supplements that resemble "typical" preferred foods and eating habits will result in improved nutritional intake and status among PWD.

Detailed Description

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Conditions

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Dementia Nutrition Poor

Keywords

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Caregiver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Group Type EXPERIMENTAL

Transitional-state food therapeutic nutrition supplement

Intervention Type DIETARY_SUPPLEMENT

Participants will consume at least one "snack-sized" package of the transitional-state food supplements per day across the intervention trial.

Interventions

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Transitional-state food therapeutic nutrition supplement

Participants will consume at least one "snack-sized" package of the transitional-state food supplements per day across the intervention trial.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Medically stable
* Community dwelling
* Has a medical diagnosis of dementia or possible dementia

Exclusion Criteria

* Does not live at home
* Cannot participate in the protocol independently and do not have a consistent caregiver who can provide assistance
* Does not have smartphone access
* Requires 100% feeding assistance
* Is NPO (nil per os)
* Has multiple food allergies
* Requires a strict renal, low-fat, and/or no-salt diet
* Is deemed unsafe for the transitional-state foods by a speech-language pathologist
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

Oregon Partnership for Alzheimer's Research

UNKNOWN

Sponsor Role collaborator

University of Oregon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Oregon

Eugene, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Barewal R, Shune S, Ball J, Kosty D. A Comparison of Behavior of Transitional-State Foods Under Varying Oral Conditions. Dysphagia. 2021 Apr;36(2):316-324. doi: 10.1007/s00455-020-10135-w. Epub 2020 May 26.

Reference Type BACKGROUND
PMID: 32458146 (View on PubMed)

Other Identifiers

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02042020.009

Identifier Type: -

Identifier Source: org_study_id