Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Part of paid clinical trials in Lexington, Kentucky.
- Sponsor
- Julie Pendergast
- Study ID
- NCT05858008
- Status
- Recruiting
Conditions
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- FEMALE
- Age
- 45 Years - 95 Years
- Healthy Volunteers
- Not accepted
Interventions
- Time-restricted eating — BEHAVIORALSubjects 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Dec 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Time-restricted eatingParticipants 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.
Primary Outcome Measure
Number of participants adhering to TRE protocol [ Time Frame: From enrollment to study completion up to approximately 8 weeks ]
Central Contacts
- Matt Thomas, PhD(859) 218-6770
- Julie S Pendergast, PhD(859) 218-6770
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 |
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