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

Julie Pendergast

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Time-restricted eating

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05858008

3R01DK124774-03S1 (U.S. NIH Grant/Contract)

81627

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Time-restricted eating

Experimental group

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.

Treatment:

Behavioral: Time-restricted eating