Time Restricted Eating in Alzheimer's Disease
Recruiting · NCT06429124 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Male or Female outpatients 55-89 years of age.
- Meet Mayo Clinic Criteria for MCI.
- If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.
- A body mass index ≥18.5 and \<40.0 kg/m2.
- Access to the internet through computer or smartphone.
- Must have a collateral informant/study partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for telephone visits/Interviews.
- An education level \> 8 years.
- A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
- Vision and hearing must be sufficient to comply with study procedures.
Exclusion criteria
- Diabetes mellitus that requires insulin treatment or is not well managed.
- An eating disorder.
- A contraindication to time-restricted eating.
- Daily eating window \<11 hours/day on ≥3 days/week.
- MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
- In the opinion of the investigator, participation would not be in the best interest of the subject.
- Taking prescription medications twice a day that need to be taken with food.
Where it is running
2 locations listed across 1 US state.
- Arizona State University, College of Health Solutions - Phoenix, Arizona, United States
- Barrow Neurological Institute, Division of Alzheimer's Disease - Phoenix, Arizona, United States