Time Restricted Eating in Alzheimer's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-89
SponsorSt. Joseph's Hospital and Medical Center, Phoenix

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dietary Intervention

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

St. Joseph's Hospital and Medical Center, Phoenix

Lead sponsor

Arizona State University

Collaborator

Karlsruhe Institute of Technology

Collaborator

Mayo Clinic

Collaborator