AzTrials
AzTrials

DementiaNCT05007730

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

A study testing Transitional-state food therapeutic nutrition supplement in people with Dementia and Nutrition Poor, run by University of Oregon at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia, Nutrition Poor
What is being tested?
Transitional-state food therapeutic nutrition supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
1 Jun 2022to 3 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Oregon

    Eugene, Oregon, 97403

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

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.

Being tested
Transitional-state food therapeutic nutrition supplement
Keywords
Caregiver
Medical subject headings
Dementia, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transitional-state food therapeutic nutrition supplementDietary supplement

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

Study groups in NCT05007730
Study groupRoleWhat they receive
Intervention ArmExperimentalNot described
Receives: Dietary Supplement: Transitional-state food therapeutic nutrition supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. 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.

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

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

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

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

Secondary outcomes (8)

  1. Change in malnutrition status (not present, present, moderate, severe)

    Malnutrition status (not present, present, moderate, severe) will be assessed via a nutrition-focused physical exam (NFPE) by a registered dietitian. The exams will be guided by the recommendations of the American Society for Parenteral and Enteral Nutrition (ASPEN) in conjunction with the Academy of Nutrition and Dietetics (AND) and use the following characteristics for diagnosing malnutrition: insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, fluid accumulation, and diminished functional status. Using published definitions of the six clinical characteristics, a diagnosis of severe malnutrition, moderate malnutrition, or not malnourished will be made.

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

  2. Change in malnutrition risk score

    A malnutrition risk score will be calculated using the Mini Nutritional Assessment-Short Form (MNA-SF). Using the information collected by a registered dietitian during a nutrition-focused physical exam, the MNA-SF will be scored; the MNA-SF is a six-item, validated, and reliable screening tool for malnutrition risk.

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

  3. Change in daily energy intake (kcal/d)

    Daily energy intake (in kcal/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

  4. Change in fat intake (g/d)

    Daily fat intake (in g/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

  5. Change in protein intake (g/d)

    Daily protein intake (in g/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

  6. Change in carbohydrate intake (g/d)

    Daily carbohydrate intake (in g/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

  7. Change in calcium intake (mg/d)

    Daily calcium intake (in mg/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

  8. Change in vitamin D intake (mg/d)

    Daily vitamin D intake (in mg/d) will be calculated based on photo-assisted, 24-hour dietary recalls completed via telephone. Three recalls will take place over the course of 2 weeks for each time point of interest.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start1 Jun 2022
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007730
Sponsor's protocol ID
02042020.009
Status last verified
Dec 2025
First submitted
28 Jul 2021
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32458146

Questions about this trial

What is this clinical trial studying?

A study testing Transitional-state food therapeutic nutrition supplement in people with Dementia and Nutrition Poor, run by University of Oregon at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant enrollment rates (%) (time frame: Measured during recruitment (at baseline, prior to study onset; week 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007730, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in