RecruitingNot ApplicableNCT06429124

Time Restricted Eating in Alzheimer's Disease

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

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Enrollment

30 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment (MCI)

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.

Eligibility

Min Age: 55 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a time-restricted eating approach (eating all meals within a specific time window each day, such as an 8- or 10-hour window) can slow or improve cognitive decline in older adults with mild cognitive impairment (MCI), an early stage that can precede Alzheimer's disease. **You may be eligible if...** - You are between 55 and 89 years old - You have been diagnosed with mild cognitive impairment (MCI) by Mayo Clinic criteria - Your weight is in the healthy-to-overweight range (BMI 18.5–40) - You have a study partner (such as a spouse or adult child) who can accompany you to some visits - You have internet access through a computer or smartphone - You have at least 8 years of formal education - You can read and speak English (or have a family member who can assist) **You may NOT be eligible if...** - You have diabetes that requires insulin or is poorly controlled - You have an eating disorder - You already eat within a restricted window of less than 11 hours most days - You have severe dementia or score very low on a cognitive test - You take prescription medications twice daily that must be taken with food Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDietary 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.