Actively Recruiting
Time Restricted Eating in Alzheimer's Disease
Led by St. Joseph's Hospital and Medical Center, Phoenix · Updated on 2025-06-06
30
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
St. Joseph's Hospital and Medical Center, Phoenix
Lead Sponsor
A
Arizona State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time Restricted Eating in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female outpatients aged 55 to 89 years
- Meet Mayo Clinic criteria for mild cognitive impairment (MCI)
- Stable dose of medications affecting study outcomes for at least 3 months
- Body mass index between 18.5 and less than 40.0 kg/m2
- Access to the internet via computer or smartphone
- Have a study partner with significant contact who can assist with visits and calls
- Education level greater than 8 years
- Proficient in English or have a family member who can translate
- Vision and hearing adequate to follow study procedures
You will not qualify if you...
- Diabetes mellitus requiring insulin or poorly controlled diabetes
- History of an eating disorder
- Contraindication to time-restricted eating
- Eating window less than 11 hours per day on 3 or more days per week
- Mini-Mental State Examination (MMSE) score less than 9 or diagnosis of severe dementia
- Investigator's judgment that participation is not in the participant's best interest
- Taking prescription medications twice daily that must be taken with food
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Arizona State University, College of Health Solutions
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
Barrow Neurological Institute, Division of Alzheimer's Disease
Phoenix, Arizona, United States, 85013
Enrolling by Invitation
Research Team
Y
Yonas E Geda, MD, MSc
CONTACT
G
Geetika Chahal, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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