Time-restricted eating for adults with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yonas.geda@commonspirit.org
• Phone: 833-233-3073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.