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Clinical Trials/NCT05858008
NCT05858008
Recruiting
Not Applicable

Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment

Julie Pendergast1 site in 1 country15 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Julie Pendergast
Enrollment
15
Locations
1
Primary Endpoint
Number of participants adhering to TRE protocol
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Detailed Description

This study will investigate the feasibility of implementing a time-restricted eating (TRE) intervention in females with mild cognitive impairment. Data will be collected for 10 weeks. Baseline food timing, activity/sleep, metabolic health (fasting labs and anthropometric measures), and cognitive testing will be collected in the first two weeks. Subjects will then be invited to enroll in a TRE intervention for 8 weeks. Subjects will be educated about the potential health benefits of TRE, and then each subject will self-select a 10-hr window and consume all daily calories during this time frame. Subjects will text the time of their first and last daily calories for the duration of the study. At the end of the 8-week TRE intervention, metabolic, anthropometric, activity/sleep, and cognitive measurements will be collected.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
June 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Julie Pendergast
Responsible Party
Sponsor Investigator
Principal Investigator

Julie Pendergast

Associate Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • Postmenopausal Women
  • Age 45-95
  • Diagnosis of mild cognitive impairment

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of participants adhering to TRE protocol

Time Frame: From enrollment to study completion up to approximately 8 weeks

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.

Study Sites (1)

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