Time-restricted eating for adults with mild cognitive impairment

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

This study is testing if a time-restricted eating plan can help improve brain function and health in adults aged 60-80 with mild cognitive impairment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 55 Years to 89 Years
• Sex: All
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix (Academic / other)
• Locations: 2 sites (Phoenix, Arizona and 1 other locations)
• Trial ID: NCT06429124 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the feasibility of implementing a time-restricted eating regimen among adults aged 60-80 with mild cognitive impairment (MCI). Participants will follow a 16/8 fasting schedule, where they fast for 16 hours and eat within an 8-hour window, five days a week for three months. The study will evaluate the impact of this dietary intervention on cognitive performance and metabolic health through neuropsychological tests and biomarker assessments. The research will also measure participant recruitment, retention, acceptability, safety, and adherence to the regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60-80 who meet the criteria for mild cognitive impairment and have a body mass index between 18.5 and 40.0.

Not a fit: Patients with diabetes requiring insulin treatment, eating disorders, or contraindications to time-restricted eating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to dietary strategies that improve cognitive function and metabolic health in individuals with mild cognitive impairment.

How similar studies have performed: While the approach of time-restricted eating is gaining interest, this specific application in mild cognitive impairment is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Male or Female outpatients 55-89 years of age.
2. Meet Mayo Clinic Criteria for MCI.
3. 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.
4. A body mass index ≥18.5 and \<40.0 kg/m2.
5. Access to the internet through computer or smartphone.
6. 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.
7. An education level \> 8 years.
8. 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.
9. Vision and hearing must be sufficient to comply with study procedures.

Exclusion Criteria:

1. Diabetes mellitus that requires insulin treatment or is not well managed.
2. An eating disorder.
3. A contraindication to time-restricted eating.
4. Daily eating window \<11 hours/day on ≥3 days/week.
5. MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.
6. In the opinion of the investigator, participation would not be in the best interest of the subject.
7. Taking prescription medications twice a day that need to be taken with food.

Where this trial is running

Phoenix, Arizona and 1 other locations

• Arizona State University, College of Health Solutions — Phoenix, Arizona, United States (Recruiting)
• Barrow Neurological Institute, Division of Alzheimer's Disease — Phoenix, Arizona, United States (Enrolling_by_invitation)

Study contacts

• Principal investigator: Yonas E Geda, MD, MSc — Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
• Study coordinator: Yonas E Geda, MD, MSc

Conditions Mild Cognitive Impairment; Alzheimer' s Disease; Intermittent Fasting; Nutritional Strategies; Time Restricted Eating