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

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-restricted eating
Sponsored by
Julie Pendergast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time-restricted eating

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants adhering to TRE protocol
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
October 9, 2023
Sponsor
Julie Pendergast
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05858008
Brief Title
Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Official Title
Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Pendergast
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted eating
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating
Intervention Description
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 Information:
Title
Number of participants adhering to TRE protocol
Description
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.
Time Frame
From enrollment to study completion up to approximately 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Thomas, PhD
Phone
(859) 218-6770
Email
jmthomg@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie S Pendergast, PhD
Phone
(859) 218-6770
Email
julie.pendergast@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Pendergast, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Thomas, PhD
Phone
859-218-6770
Email
jmthomg@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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