20 Participants Needed

Nutritional Snacks for Dementia

Recruiting at 1 trial location
SS
Overseen BySamantha Shune, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oregon
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new snack that changes texture during consumption, designed to improve nutrition for people with dementia. The goal is to determine if these snacks, known as transitional-state food therapeutic nutrition supplements, can help maintain better physical and mental health by simplifying nutrient intake. It suits individuals with dementia who live at home and are medically stable. Participants should be able to use a smartphone and either manage eating independently or with a caregiver's assistance.

As an unphased trial, this study provides a unique opportunity to contribute to innovative nutritional solutions for dementia care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this nutritional supplement is safe for adults with dementia?

Researchers are investigating a special food supplement for adults with dementia to determine its safety. This study examines how well participants tolerate the supplement. It begins with one texture and transitions to another, making it easier to consume.

Past studies have not provided clear information about its safety, so this trial aims to explore that aspect. As an early-stage study, researchers are still gathering safety data. If effective, the supplement could enhance nutrition for people with dementia without causing harm. Currently, the primary goal is to ensure it is safe and easy for participants to eat.12345

Why are researchers excited about this trial?

Unlike the standard treatments for dementia, which typically focus on medications to manage symptoms, this new approach uses a transitional-state food therapeutic nutrition supplement. This treatment is unique because it focuses on nutrition to potentially improve cognitive function and overall health in dementia patients. Researchers are excited because it offers a non-pharmacological option, which might reduce the risk of side effects associated with traditional medications, and it could provide a more holistic approach to managing dementia.

What evidence suggests that this nutritional supplement is effective for improving nutrition in dementia?

Research has shown that oral nutrition supplements (ONS) can greatly increase energy and protein intake in people with dementia, leading to better overall nutrition. Good nutrition is crucial for maintaining both body and brain health in those with dementia. In this trial, participants in the intervention arm will receive the transitional-state therapeutic nutrition supplement. This supplement aims to enhance these benefits by providing snacks with altered textures, making them more enjoyable to eat. By resembling familiar foods, these snacks are designed to help people with dementia obtain necessary nutrients more easily.13467

Are You a Good Fit for This Trial?

This trial is for stable adults living at home with a medical diagnosis of dementia or possible dementia. They must be able to participate in the study protocol on their own or have a caregiver who can assist, and they need smartphone access. People who require full feeding assistance, are NPO (nothing by mouth), have multiple food allergies, or need strict renal, low-fat/no-salt diets cannot join.

Inclusion Criteria

My health condition is currently stable.
I have been diagnosed with dementia.
Community dwelling

Exclusion Criteria

Does not live at home
Is NPO (nil per os)
A speech therapist has advised against certain foods for me.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants consume transitional-state snack supplements to improve nutritional intake

8 weeks
Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Transitional-state food therapeutic nutrition supplement
Trial Overview The study tests if transitional-state snacks—foods that change texture—can improve nutrition in people with dementia. These savory snacks resemble regular foods and aim to enhance physical and cognitive health by improving dietary intake.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials
91
Recruited
46,700+

Oregon Partnership for Alzheimer's Research

Collaborator

Trials
2
Recruited
20+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Published Research Related to This Trial

In a study of 82 long-term care residents with dementia, most were found to be malnourished or at risk of malnutrition, indicating a significant decline in food intake and appetite compared to previous reports.
Factors such as comorbid illnesses and depressed mood explained a substantial portion of the variance in food intake, suggesting that addressing these issues could improve nutritional status and overall function in this vulnerable population.
Factors associated with food intake, nutritional status, and function among nursing home residents with dementia.Plotkin, A., Taani, MH.[2021]
In a randomized trial involving 34 elderly in-patients with poor appetite, both a standard and a nutrient-dense liquid supplement were tested over 10 days, with 24 patients completing the study.
Neither supplement reduced energy intake from the hospital diet; in fact, those on the standard product slightly increased their overall intake, suggesting that these supplements can be beneficial without negatively impacting regular food consumption.
The effect of a supplement which is nutrient dense compared to standard concentration on the total nutritional intake of anorectic patients.Ovesen, L.[2019]
Oral nutrition supplements (ONS) significantly improved energy and protein intake in 407 individuals with dementia, leading to better nutritional status without affecting their regular food intake.
While ONS enhanced body weight, muscle mass, and nutritional biomarkers, no improvements in cognitive or physical outcomes were observed, indicating the need for longer studies to assess these effects.
Effects of oral nutrition supplements in persons with dementia: A systematic review.Tangvik, RJ., Bruvik, FK., Drageset, J., et al.[2021]

Citations

NCT05007730 | Enhancing Health and Quality of Life for ...Specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement among adults ...
Enhancing Health and Quality of Life for Individuals With ...This project will pilot an innovative approach to enhancing nutrition through the use of transitional-state snack supplements, or foods that ...
Nutritional Snacks for DementiaOral nutrition supplements (ONS) significantly improved energy and protein intake in 407 individuals with dementia, leading to better nutritional status without ...
Study Details | Enhancing Health and Quality of Life for ...A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...
Nutrition and dementia: A review of available research2 To develop, evaluate, and promote primary care and community interventions for people with dementia.
Enhancing Health and Quality of Life for Individuals With ...Specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement ...
Nutrition and dementia8 There is no current evidence that nutritional supplementation whether with micronutrients or macronutrients can modify the course of dementia (cognitive and ...
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