Time Restricted Eating in Alzheimer's Disease (TREAD)

St. Joseph's Hospital and Medical Center, Phoenix

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Behavioral: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06429124

HX-23-500-347-30-03

Details and patient eligibility

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.

Full description

The goal of this pilot study on time restricted eating regimens in the mild cognitive impairment (MCI) patient population will be to determine the feasibility of implementing the intervention and impact of time-restricted eating on cognitive performance and biomarkers of metabolic health. Researchers at the Barrow Neurological Institute, Alzheimer's Disease Program in collaboration with the Arizona State University College of Health Solutions will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of 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. Primary outcomes will include participant recruitment, retention, acceptability, safety, and adherence to the 16 hours of fasting and 8-hour eating window. Researchers hypothesize that participants who follow a time-restricted eating pattern will have improvements in attention, working memory and semantic fluency domains. Study staff hypothesize that there will be improvements or trends toward improvements in inflammatory and cardiometabolic biomarkers (i.e., interleukin-6, tumor necrosis factor alpha, C-reactive protein, insulin, hemoglobin A1c, and lipids).

The results of this project will provide critical preliminary data for a longer-term, large-scale, randomized controlled trial of time-restricted eating on cognitive trajectory among adults with MCI. The novel findings from the proposed project and future studies will contribute significantly to the body of knowledge that will advance the field, with the ultimate goal of preventing or delaying the progression of MCI to dementia.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 60-80 years
2. meet criteria for MCI
3. body mass index >18.5 and <40.0 kg/m2
4. access to the internet through computer or smart phone
5. supportive family member (e.g., spouse or adult child) who will help to facilitate study visits and intervention activities
6. education level > 8 years
7. 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.

Exclusion criteria

1. diabetes mellitus that requires insulin treatment or is not well managed
2. eating disorder
3. contraindication to time-restricted eating

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Interventional

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary Intervention