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 — BEHAVIORAL
    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.

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 eating
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Matt Thomas, PhD
(859) 218-6770

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