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RECRUITING
NCT06429124
NA

Time Restricted Eating in Alzheimer's Disease

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

View on ClinicalTrials.gov

Summary

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.

Official title: Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial

Key Details

Gender

All

Age Range

55 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-03-15

Completion Date

2026-03-14

Last Updated

2025-06-06

Healthy Volunteers

No

Interventions

BEHAVIORAL

Dietary Intervention

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.

Locations (2)

Arizona State University, College of Health Solutions

Phoenix, Arizona, United States

Barrow Neurological Institute, Division of Alzheimer's Disease

Phoenix, Arizona, United States