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

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Time-restricted eating

• Registration Number: NCT05858008
• Lead Sponsor: Julie Pendergast

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.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-15
• Study Start: 2024-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time-restricted eating	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 Measures

Name	Time	Method
Number of participants adhering to TRE protocol	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States