Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks
- Conditions
- DementiaNutrition Poor
- Interventions
- Dietary Supplement: Transitional-state food therapeutic nutrition supplement
- Registration Number
- NCT05007730
- Lead Sponsor
- University of Oregon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Medically stable
- Community dwelling
- Has a medical diagnosis of dementia or possible dementia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Arm Transitional-state food therapeutic nutrition supplement -
- Primary Outcome Measures
Name Time Method Proportion of participants deemed eligible to consume transitional-state foods Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0) 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.
Number of test snacks consumed each week Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8) 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)
Participant retention rates (%) Measured at the end of the study (post-intervention, after 8 weeks of snack consumption) 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
Change in acceptability of nutrition supplements Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8) 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)
Participant enrollment rates (%) Measured during recruitment (at baseline, prior to study onset; week 0) 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)
- Secondary Outcome Measures
Name Time Method Change in protein intake (g/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in malnutrition risk score Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in carbohydrate intake (g/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in calcium intake (mg/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in fat intake (g/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in malnutrition status (not present, present, moderate, severe) Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in daily energy intake (kcal/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Change in vitamin D intake (mg/d) Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption) 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.
Trial Locations
- Locations (2)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Oregon
🇺🇸Eugene, Oregon, United States