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NCT Number: NCT05858008

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

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.

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Key information

Age range

45 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Matt Thomas, PhD

CONTACT

[email protected]

(859) 218-6770

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Julie S Pendergast, PhD

CONTACT

[email protected]

(859) 218-6770

Matt Thomas, PhD

CONTACT

[email protected]

(859) 218-6770

Sponsors and collaborators

Lead sponsor

Julie Pendergast

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 15, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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