Nutritional Snacks for Dementia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oregon
Disqualifiers: No smartphone, 100% feeding assistance, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789How 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.
110111213Eligibility 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.
+5 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of OregonEugene, OR
Oregon Health & Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
University of OregonLead Sponsor
Oregon Partnership for Alzheimer's ResearchCollaborator
Oregon Health and Science UniversityCollaborator
References
Effects of oral nutrition supplements in persons with dementia: A systematic review. [2021]Persons with dementia are at risk of malnutrition, evidenced by low dietary intake, which has consequences for nutritional status, activity of daily living and disease progression. The effects of oral nutrition supplements (ONS) on nutritional intake, nutritional status, and cognitive and physical outcomes in older persons with dementia were evaluated.
Gaining strength: supplements revised. [2005]Responding to concerns for weight loss and nutritional status of its patients, a Transitional Care Unit (TCU) began an intensive Medication Pass Supplement Program. It involves nurses administering a dietitian-reviewed and approved nutritional supplement for specified residents with every medication pass. As a result, 94% of discharged patients lost less than 5% of their admission weight.
Three-week nutritional supplementation effect on long-term nutritional status of patients with mild Alzheimer disease. [2015]Short-term nutritional supplements enable an improvement in Alzheimer patients' nutritional status, but it remains to be seen whether they will be sufficient to improve long-term nutritional status. The aim of this study was to evaluate the long-term impact of a 3-week nutritional supplementation on the nutritional status of undernourished patients with probable mild Alzheimer disease. A 21-day prospective randomized nonblinded controlled trial was conducted. Patients were followed-up for an additional period until the 90th day after the beginning of the intervention. Intervention resulted in significant improvements in Mini Nutritional Assessment (MNA) score [Mean=1.4, standard deviation (SD)=0.8 vs. 0.0 (0.1) in the control group, P
A cross-sectional, observational study of nutritional status and eating behaviours in people living with dementia in acute care settings. [2023]To understand the nutritional status, observing eating difficulties during mealtimes for people living with dementia in acute care settings.
Prevention of weight loss in dementia with comprehensive nutritional treatment. [2019]To determine whether body weight can be maintained or improved in dementia residents of special care units (SCUs) using a comprehensive intervention strategy.
Factors associated with food intake, nutritional status, and function among nursing home residents with dementia. [2021]Declined food intake is prevalent among long-term care (LTC) residents with dementia and associated with deleterious health outcomes. This study explores food intake, nutritional status, and function and its associated factors in LTC residents with dementia. Data from 82 LTC residents with dementia were used in this secondary analysis. The majority of residents were either malnourished or at risk of being malnourished and demonstrated a worse appetite than previously described in the literature. Comorbid illness, depressed mood, and appetite were associated with 37.1% of the variance in food intake over 30 days. Dementia level and appetite were associated with 22.2% of the variance in nutritional status. Food intake and nutritional status were associated with 29.1% of the variance in function. This study also highlights a new demographic that may require extra assistance in combating declined food intake: LTC residents with dementia who reside in a facility that follows restrictive food practices such as a kosher diet. The potential reversibility of factors associated with food intake and nutritional status provides opportunities for intervention.
The effect of a supplement which is nutrient dense compared to standard concentration on the total nutritional intake of anorectic patients. [2019]A randomised, double-blind trial was conducted to compare the intake of a standard (4.2kJ/ml) and a nutrient dense (6.3kJ/ml) commericial liquid supplement, and to assess their effect on total nutrient intake. Both products were offered as a supplement to the regular hospital diet to 34 elderly in-patients with poor appetite and intake. Only 24 of these patients completed the entire supplementation period of 10 days. Median (interquartile range) volumes of intake were 300 (200-400) ml of the standard product and 400 (250-500) ml of the nutrient dense product (NS). Neither product decreased energy intake from the hospital diet. In fact, patients on the standard product increased slightly their intake from the hospital diet. This was enough to outweigh the increased contribution to total energy intake provided by the nutrient dense product. Both products received high palatability ratings, but high ratings did not imply high volume intake or good compliance.
Enhancement of select foods at breakfast and lunch increases energy intakes of nursing home residents with low meal intakes. [2009]Nursing facilities often provide enhanced or fortified foods as part of a "food-first" approach to increasing nutrient intakes in residents with inadequate intakes or who are experiencing weight loss. The study objective was to determine whether energy and protein enhancement of a small number of menu items would result in increased three-meal (breakfast, lunch, and supper) calorie and protein intakes in long-term care residents.
The influence of nutritional supplement drinks on providing adequate calorie and protein intake in older adults with dementia. [2021]Investigate the impact of the provision of ONS on protein and energy intake from food and ability to meet protein and calorie requirements in people with dementia.
Improving food intake in persons living with dementia. [2022]Persons living with dementia have many health concerns, including poor nutritional states. This narrative review provides an overview of the literature on nutritional status in persons diagnosed with a dementing illness or condition. Poor food intake is a primary mechanism for malnutrition, and there are many reasons why poor food intake occurs, especially in the middle and later stages of the dementing illness. Research suggests a variety of interventions to improve food intake, and thus nutritional status and quality of life, in persons with dementia. For family care partners, education programs have been the focus, while a range of intervention activities have been the focus in residential care, from tableware changes to retraining of self-feeding. It is likely that complex interventions are required to more fully address the issue of poor food intake, and future research needs to focus on diverse components. Specifically, modifying the psychosocial aspects of mealtimes is proposed as a means of improving food intake and quality of life and, to date, is a neglected area of intervention development and research.
[Nutrition and Dementia - Dementia and Nutrition]. [2023]Nutrition and Dementia - Dementia and Nutrition Abstract: Nutritional aspects play an important role both in the prevention of dementia and in its course. There is a mutual relationship between cognitive impairment and nutrition. In terms of prevention, nutrition is one of the potentially modifiable risk factors for the development of the disease, since it can influence both the structures and the functionality of the brain in a variety of ways. A food selection based on the traditional Mediterranean diet or on a generally healthy diet also seems to be advantageous for maintaining cognitive function. In the course of dementia, various symptoms of the disease sooner or later lead to nutritional problems, which make it difficult to achieve a varied, needs-based diet and are associated with an increased risk of a qualitatively and quantitatively inadequate nutrition. In order to maintain a good nutritional status in people with dementia for as long as possible, early detection of nutritional problems is fundamental. Strategies for the prevention and treatment include the elimination of potential causes of malnutrition and various supportive measures to promote adequate eating. The diet itself can be supported by an attractive, varied range of food, additional snacks, enrichment of the food with energy and nutrients and by oral nutritional supplements. Enteral or parenteral administration of nutrients, on the other hand, should be reserved for justified exceptional cases.
Fingerfoods: a feasibility study to enhance fruit and vegetable consumption in Dutch patients with dementia in a nursing home. [2023]Eating problems are highly prevalent in older patients with dementia and as a consequence, these patients are at greater risk of becoming malnourished. Fingerfoods, snacks that can be picked with thumb and forefinger, could be used to counteract malnutrition in patients with dementia. The aim of this feasibility study was to evaluate whether providing fruit and vegetable rich fingerfoods in the form of recognizable and familiar snacks on top of the normal intake was feasible for both patients with dementia and caregivers as a means to increase patients' nutritional status.
Evidence supporting nutritional interventions for persons in early stage Alzheimer's disease (AD). [2019]The purpose of this paper is to grade research evidence supporting nutritional interventions for persons with early stage dementias and to report the recommendations of a consensus panel. Thirty four studies were reviewed in the areas of dietary restriction, antioxidants, and Mediterranean diet with strong support from epidemiological studies found in all three areas. The body of evidence to support nutritional interventions in the prevention and treatment of AD is growing and has potential as a treatment modality following translational studies.