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

NCT ID: NCT05858008

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Time-restricted eating

Intervention Type 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.

Interventions

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Time-restricted eating

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Julie Pendergast

OTHER

Sponsor Role lead

Responsible Party

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Julie Pendergast

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Julie Pendergast, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matt Thomas, PhD

Role: CONTACT

Phone: (859) 218-6770

Email: [email protected]

Julie S Pendergast, PhD

Role: CONTACT

Phone: (859) 218-6770

Email: [email protected]

Facility Contacts

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Matt Thomas, PhD

Role: primary

Other Identifiers

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3R01DK124774-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

81627

Identifier Type: -

Identifier Source: org_study_id