Time Restricted Eating in Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT06429124
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
55 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary Intervention — BEHAVIORAL
    Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.

Study Details

This pilot and feasibility study will enable the research team to determine the feasibility of implementing a time-restricted eating regimen among adults with mild cognitive impairment (MCI) and the impact of time-restricted eating on cognitive performance and biomarkers of metabolic health in this population. Study staff will execute the specific aims using a pre-post, non-randomized study design in which all participants receive the intervention. The intervention is a 16/8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months. Assessments will be performed at baseline and after the 3-month time-restricted eating intervention with the following outcome measures. Outcome measures for feasibility include participant recruitment, retention and metrics of acceptability, safety, and adherence to the intervention. Outcome measures for cognitive performance and metabolic health include neuropsychological tests, blood biomarkers, and surveys of psychological well-being.

Key Dates

Start date
Mar 15, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Mar 14, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Interventional
    Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.

Primary Outcome Measure

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arizona State University, College of Health SolutionsPhoenixArizona85004
Susan Racette, Ph.D.
[email protected]
602-543-1563
Barrow Neurological Institute, Division of Alzheimer's DiseasePhoenixArizona85013-

Find similar trials in Phoenix, AZ

By research site
Arizona State University, College of Health Solutions· Phoenix, AZBarrow Neurological Institute, Division of Alzheimer's Disease· Phoenix, AZ

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