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

NCT05007730 | Completed

• 1 other identifier: 02042020.009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dementia; Nutrition Poor

Keywords

Caregiver

Outcome Measures

Primary Outcomes (5)

• Participant enrollment rates (%)

  The percentage of participants enrolled (i.e., who meet all eligibility criteria) as compared to the total number of participants who are recruited (i.e., initiate contact with the research team)

  Measured during recruitment (at baseline, prior to study onset; week 0)

• Proportion of participants deemed eligible to consume transitional-state foods

  Instrumental swallowing assessments will be conducted for each participant by a licensed speech-language pathologist to determine whether the potential participant can safely consume transitional-state foods based on their swallowing physiology. The number of potential participants deemed eligible to consume this consistency of food will be compared to the total number of potential participants receiving the swallow study.

  Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0)

• Participant retention rates (%)

  The percentage of participants retained (i.e., who who remain enrolled and participate for the duration of the study) as compared to the total number of participants who are enrolled

  Measured at the end of the study (post-intervention, after 8 weeks of snack consumption)

• Change in acceptability of nutrition supplements

  Using a Likert (5 point) rating scale, participants will rate their acceptability of the nutrition supplements each week. Change in acceptability will be calculated over the length of the study (e.g., increased or decreased acceptability over time)

  Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)

• Number of test snacks consumed each week

  As a measured of adherence to the protocol, participants will document the total number of test snacks consumed each week (protocol is for at least one snack per day)

  Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)

Secondary Outcomes (8)

• Change in malnutrition status (not present, present, moderate, severe)

  Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)

• Change in malnutrition risk score

  Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)

• Change in daily energy intake (kcal/d)

  Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)

• Change in fat intake (g/d)

  Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)

• Change in protein intake (g/d)

  Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Dietary Supplement: Transitional-state food therapeutic nutrition supplement

Interventions

Transitional-state food therapeutic nutrition supplement DIETARY_SUPPLEMENT

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oregon: lead
• Oregon Health and Science University: collaborator
• Oregon Partnership for Alzheimer's Research: collaborator

Study Sites (2)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 32458146 BACKGROUND

MeSH Terms

Conditions

Dementia; Malnutrition

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 16, 2021
• Study Start: June 1, 2022
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)