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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia, Nutrition Poor

Intervention / Treatment
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* Dietary Supplement: Transitional-state food therapeutic nutrition supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable Community dwelling Has a medical diagnosis of dementia or possible dementia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br> | Dietary Supplement: Transitional-state food therapeutic nutrition supplement<br>* Participants will consume at least one snack-sized package of the transitional-state food supplements per day across the intervention trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 during recruitment (at baseline, prior to study onset; week 0) | 
| 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. | Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0) | 
| 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 at the end of the study (post-intervention, after 8 weeks of snack consumption) | 
| 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 weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8) | 
| 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 weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption) | 
| 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 at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 
| 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. | Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver