Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
2 other identifiers
interventional
15
1 country
1
Brief Summary
This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 15, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 29, 2025
December 1, 2025
2.2 years
May 4, 2023
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants adhering to TRE protocol
The times of first and last meals will be collected from participants with an SMS texting system. Adherence defined as minimum 10 hour (+/- 1hr) TRE window 5 days per week.
From enrollment to study completion up to approximately 8 weeks
Study Arms (1)
Time-restricted eating
EXPERIMENTALParticipants will have baseline and post-study data collected, including activity/sleep data, metabolic parameters (fasting labs and anthropometric measurements), and cognitive testing. In addition, food timing will be collected throughout the study. Subjects will be educated about the potential health benefits of time-restricted eating and will self-select a 10-hr window, during which all daily calories will be consumed for 8 weeks.
Interventions
Subjects will be educated about the health benefits of time-restricted eating. Each subject will self-select a 10-hour (10hr +/- 1 hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily calories for the duration of the study.
Eligibility Criteria
You may qualify if:
- Postmenopausal Women
- Age 45-95
- Diagnosis of mild cognitive impairment
You may not qualify if:
- Individuals prone to hypoglycemia
- Liver disease
- Taking medications that affect eating behaviors
- Alcohol consumption of \>2 drinks per day
- Significant circadian disruption
- Having care-taking responsibilities that significantly affect sleep
- Shift work or irregular lifestyle
- Diagnosed clinical eating disorder
- Participating in a formal weight loss program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Pendergast, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 4, 2023
First Posted
May 15, 2023
Study Start
April 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share