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)

Trial Summary

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 data supports the effectiveness of the treatment Transitional-state food therapeutic nutrition supplement for dementia?

Research shows that oral nutrition supplements can improve nutritional intake and status in people with dementia, which may help with daily activities and slow disease progression. Additionally, a study found that a 3-week nutritional supplementation improved the nutritional status of patients with mild Alzheimer's disease.12345

Is the nutritional snack treatment safe for humans?

Research on similar nutritional supplements shows they are generally safe for elderly patients, including those with dementia, as they help improve nutritional intake without negative effects.16789

How is the Transitional-state food therapeutic nutrition supplement treatment different from other treatments for dementia?

This treatment is unique because it focuses on providing nutritional snacks specifically designed to address malnutrition in dementia patients, which is a common issue due to eating problems. Unlike other treatments that may focus on medication or lifestyle changes, this approach uses familiar and easy-to-eat snacks to improve nutritional intake and support cognitive function.110111213

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
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+

Findings from Research

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]
The Transitional Care Unit implemented a Medication Pass Supplement Program, where nurses provide nutritional supplements during medication passes, effectively addressing weight loss concerns among patients.
As a result of this program, 94% of discharged patients experienced less than 5% weight loss from their admission weight, indicating the program's efficacy in maintaining nutritional status.
Gaining strength: supplements revised.Lewis, D., Boyle, KD.[2005]
A 3-week nutritional supplementation significantly improved the nutritional status of undernourished patients with mild Alzheimer's disease, as indicated by a notable increase in the Mini Nutritional Assessment (MNA) score.
These improvements were not only immediate but also sustained over a 90-day follow-up period, suggesting that short-term nutritional interventions can have lasting benefits for Alzheimer's patients.
Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease.de Sousa, OL., Amaral, TF.[2015]

References

Effects of oral nutrition supplements in persons with dementia: A systematic review. [2021]
Gaining strength: supplements revised. [2005]
Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease. [2015]
A cross-sectional, observational study of nutritional status and eating behaviours in people living with dementia in acute care settings. [2023]
Prevention of weight loss in dementia with comprehensive nutritional treatment. [2019]
Factors associated with food intake, nutritional status, and function among nursing home residents with dementia. [2021]
The effect of a supplement which is nutrient dense compared to standard concentration on the total nutritional intake of anorectic patients. [2019]
Enhancement of select foods at breakfast and lunch increases energy intakes of nursing home residents with low meal intakes. [2009]
The influence of nutritional supplement drinks on providing adequate calorie and protein intake in older adults with dementia. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Improving food intake in persons living with dementia. [2022]
[Nutrition and Dementia - Dementia and Nutrition]. [2023]
Fingerfoods: a feasibility study to enhance fruit and vegetable consumption in Dutch patients with dementia in a nursing home. [2023]
Evidence supporting nutritional interventions for persons in early stage Alzheimer's disease (AD). [2019]
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