Recruiting

Time-restricted Eating

Sponsor:

Julie Pendergast

Code:

NCT05858008

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating

Study Details

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.

Conditions

Mild Cognitive Impairment

Study ID

NCT05858008

Start date

Apr 1, 2024

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Number of participants adhering to TRE protocol [ Time Frame: From enrollment to study completion up to approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Matt Thomas, PhD

(859) 218-6770jmthomg@uky.edu

Julie S Pendergast, PhD

(859) 218-6770julie.pendergast@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Matt Thomas, PhD

(859) 218-6770jmthomg@uky.edu

More Information

Sponsor

Julie Pendergast

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Julie Pendergast on 2026-07-06.