Nutritional Snacks for Dementia

No longer recruiting at 1 trial location

Overseen By Samantha Shune, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: No smartphone, 100% feeding assistance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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.

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?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral nutrition supplements in persons with dementia: A systematic review. Tangvik, RJ., Bruvik, FK., Drageset, J., et al.[2021]

Poor food intake is a major cause of malnutrition in individuals with dementia, particularly in the middle and later stages of the disease.

Interventions to improve nutritional status should be multifaceted, focusing on both education for family caregivers and changes in mealtime environments, as enhancing the psychosocial aspects of mealtimes has been overlooked but could significantly improve food intake and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving food intake in persons living with dementia. Keller, HH.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaining strength: supplements revised. Lewis, D., Boyle, KD.[2005]

Enhancing breakfast foods significantly increased calorie intake for bigger eaters, while smaller eaters benefited from enhancements at either breakfast or lunch, indicating that targeted food enhancements can effectively increase energy intake in nursing home residents.

To effectively combat undernutrition in smaller eaters, the study suggests that a food enhancement program should include multiple enhanced items across different meals, as overall daily protein intake did not see substantial increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of select foods at breakfast and lunch increases energy intakes of nursing home residents with low meal intakes. Castellanos, VH., Marra, MV., Johnson, P.[2009]

In a feasibility study involving 15 institutionalized dementia patients, providing fruit and vegetable-rich fingerfoods significantly increased their daily intake of these foods without leading to compensation at mealtimes.

Caregivers generally found the fingerfood intervention to be well-received, suggesting that this approach could be a practical way to improve nutritional status in elderly patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fingerfoods: a feasibility study to enhance fruit and vegetable consumption in Dutch patients with dementia in a nursing home. Visscher, A., Battjes-Fries, MCE., van de Rest, O., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease. de Sousa, OL., Amaral, TF.[2015]

A comprehensive intervention strategy, including enhanced dietitian monitoring and menu changes, significantly promoted weight gain in dementia residents of special care units, compared to standard treatment.

Maintaining or gaining at least 5% body weight was linked to improved survival rates, indicating the importance of tailored nutritional support for residents with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of weight loss in dementia with comprehensive nutritional treatment. Keller, HH., Gibbs, AJ., Boudreau, LD., et al.[2019]

In a study involving 26 older adults with dementia, the provision of oral nutritional supplements (ONS) significantly increased the number of participants meeting their protein and energy intake requirements, suggesting a potential solution to malnutrition in this population.

The use of ONS did not negatively impact the consumption of regular food, indicating that these supplements can be effectively integrated into the diets of individuals with dementia to enhance overall nutritional intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of nutritional supplement drinks on providing adequate calorie and protein intake in older adults with dementia. Allen, V., Methven, L., Gosney, M.[2021]

Nutrition plays a crucial role in both preventing dementia and managing its progression, with a healthy diet, particularly the Mediterranean diet, linked to better cognitive function.

In individuals with dementia, nutritional problems can arise due to the disease's symptoms, making it essential to detect these issues early and implement strategies to ensure adequate nutrition, such as providing appealing food options and nutritional supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and Dementia - Dementia and Nutrition]. Volkert, D.[2023]

A review of 34 studies indicates that nutritional interventions, including dietary restriction, antioxidants, and the Mediterranean diet, show strong epidemiological support for their potential benefits in early-stage dementia.

The evidence suggests that these nutritional strategies could play a significant role in the prevention and treatment of Alzheimer's disease, highlighting the need for further translational studies to explore their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence supporting nutritional interventions for persons in early stage Alzheimer's disease (AD). Burgener, SC., Buettner, L., Coen Buckwalter, K., et al.[2019]

In a study of 94 people living with dementia in acute care settings, 72.1% were found to be malnourished, highlighting a significant risk of malnutrition in this population.

The research indicates that individuals with higher mealtime difficulties require longer feeding times and all participants needed assistance, suggesting that training programs for caregivers and nursing staff could improve feeding practices and nutritional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional, observational study of nutritional status and eating behaviours in people living with dementia in acute care settings. Lin, PH., Ataiza, C., Ho, MH., et al.[2023]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05007730

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 ...

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centerwatch.com/clinical-trials/listings/NCT05007730/enhancing-health-and-quality-of-life-for-individuals-with-dementia-through-transitional-state-snacks

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 ...

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withpower.com

withpower.com/trial/phase-dementia-8-2021-125ec

Nutritional Snacks for Dementia

Oral nutrition supplements (ONS) significantly improved energy and protein intake in 407 individuals with dementia, leading to better nutritional status without ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05007730?term=AREA%5BConditionSearch%5D(Diseases%20of%20poverty)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=8

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 ...

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alzint.org/u/nutrition-and-dementia.pdf

Nutrition and dementia: A review of available research

2 To develop, evaluate, and promote primary care and community interventions for people with dementia.

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trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/300765

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 ...

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alzint.org

alzint.org/u/nutrition-dementia-summary.pdf

Nutrition and dementia

8 There is no current evidence that nutritional supplementation whether with micronutrients or macronutrients can modify the course of dementia (cognitive and ...