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

Inclusion Criteria9

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 Criteria7

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.

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.