Clinical trial NCT05007730: Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks
Official title: Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Nutrition Poor
Keywords: Caregiver
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Oregon Partnership for Alzheimer's Research
First posted: 2021-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant enrollment rates (%)
timeFrame: Measured during recruitment (at baseline, prior to study onset; week 0)
measure: Proportion of participants deemed eligible to consume transitional-state foods
timeFrame: Prior to enrollment (to determine eligibility at baseline, prior to study onset; week 0)
measure: Participant retention rates (%)
timeFrame: Measured at the end of the study (post-intervention, after 8 weeks of snack consumption)
measure: Change in acceptability of nutrition supplements
timeFrame: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)
measure: Number of test snacks consumed each week
timeFrame: Measured weekly for enrolled participants (weeks 1, 2, 3, 4, 5, 6, 7, 8)
Secondary outcomes:
measure: Change in malnutrition status (not present, present, moderate, severe)
timeFrame: Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in malnutrition risk score
timeFrame: Measured at baseline (study onset) and post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in daily energy intake (kcal/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in fat intake (g/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in protein intake (g/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in carbohydrate intake (g/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in calcium intake (mg/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
measure: Change in vitamin D intake (mg/d)
timeFrame: Baseline (study onset), mid-intervention (approximately 4 weeks into the trial), post-intervention (end of study after 8 weeks of snack consumption)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: Barewal R, Shune S, Ball J, Kosty D. A Comparison of Behavior of Transitional-State Foods Under Varying Oral Conditions. Dysphagia. 2021 Apr;36(2):316-324. doi: 10.1007/s00455-020-10135-w. Epub 2020 May 26.