RECRUITING

Time Restricted Eating in Alzheimer's Disease (TREAD)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time-Restricted Eating in Alzheimer's Disease : the T.R.E.A.D Trial

Quick Facts

Study Start:2023-03-15
Study Completion:2026-03-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. aged 60-80 years
  2. 2. meet criteria for MCI
  3. 3. body mass index \>18.5 and \<40.0 kg/m2
  4. 4. access to the internet through computer or smart phone
  5. 5. supportive family member (e.g., spouse or adult child) who will help to facilitate study visits and intervention activities
  6. 6. education level \> 8 years
  7. 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.
  1. 1. diabetes mellitus that requires insulin treatment or is not well managed
  2. 2. eating disorder
  3. 3. contraindication to time-restricted eating

Contacts and Locations

Study Contact

Yonas E Geda, MD, MSc
CONTACT
833-233-3073
yonas.geda@commonspirit.org
Geetika Chahal, MBBS
CONTACT
602-406-7240
geetika.chahal@commonspirit.org

Principal Investigator

Yonas E Geda, MD, MSc
PRINCIPAL_INVESTIGATOR
Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

Study Locations (Sites)

Arizona State University, College of Health Solutions
Phoenix, Arizona, 85004
United States
Barrow Neurological Institute, Division of Alzheimer's Disease
Phoenix, Arizona, 85013
United States

Collaborators and Investigators

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

  • Yonas E Geda, MD, MSc, PRINCIPAL_INVESTIGATOR, Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2026-03-14

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2026-03-14

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer&#39;s Disease
  • Mild Cognitive Impairment
  • Intermittent Fasting
  • Nutritional Strategies
  • Time Restricted Eating

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment (MCI)