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

Sponsor

Julie Pendergast (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05858008

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: Time-restricted eating	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: 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.

Arm

Intervention/Treatment

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 95 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Postmenopausal Women
Age 45-95
Diagnosis of mild cognitive impairment

Exclusion Criteria:

On hormone therapy
Taking medications for diabetes
Individuals prone to hypoglycemia
Liver disease
Taking medications that affect eating behaviors
Alcohol consumption of >2 drinks per day
Significant circadian disruption
Living with children under 2 years old
Shift work or irregular lifestyle
Uncontrolled sleep apnea or other diagnosed sleep disorders
Significant psychiatric disorders
History of dysregulated eating behaviors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

Julie Pendergast

Investigators

Principal Investigator: Julie Pendergast, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Julie Pendergast, Associate Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT05858008

Other Study ID Numbers:

81627

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of May 15, 2023