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Completed

NCT Number: NCT05007730

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Malnutrition Mental Disorders Nervous System Diseases Neurocognitive Disorders Nutrition Disorders Nutrition Poor Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon, Eugene, Oregon, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transitional-state food therapeutic nutrition supplement

Dietary Supplement

Participants will consume at least one "snack-sized" package of the transitional-state food supplements per day across the intervention trial.

Primary outcomes

  1. Participant enrollment rates (%)

    Time frame: 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)

  2. Proportion of participants deemed eligible to consume transitional-state foods

    Time frame: 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.

  3. Participant retention rates (%)

    Time frame: 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

  4. Change in acceptability of nutrition supplements

    Time frame: 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)

  5. Number of test snacks consumed each week

    Time frame: 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)

Secondary outcomes

  1. Change in malnutrition status (not present, present, moderate, severe)

    Time frame: 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.

  2. Change in malnutrition risk score

    Time frame: 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.

  3. Change in daily energy intake (kcal/d)

    Time frame: 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.

  4. Change in fat intake (g/d)

    Time frame: 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.

  5. Change in protein intake (g/d)

    Time frame: 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.

  6. Change in carbohydrate intake (g/d)

    Time frame: 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.

  7. Change in calcium intake (mg/d)

    Time frame: 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.

  8. Change in vitamin D intake (mg/d)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • Oregon Health and Science University
  • Oregon Partnership for Alzheimer's Research

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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