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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858008
• Other study ID #: 81627
• Secondary ID: 3R01DK124774-03S
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Matt Thomas, PhD
• Phone: (859) 218-6770
• Email: jmthomg[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Julie Pendergast	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From enrollment to study completion up to approximately 8 weeks