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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05007730
• Other study ID #: 02042020.009
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Oregon
• Contact: Samantha Shune, PhD
• Phone: 541-346-7494
• Email: sshune[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Malnutrition
• Nutrition Poor

Intervention

Dietary Supplement:
• Transitional-state food therapeutic nutrition supplement
Participants will consume at least one "snack-sized" package of the transitional-state food supplements per day across the intervention trial.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
University of Oregon	Oregon Health and Science University, Oregon Partnership for Alzheimer's Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)