Mild Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALTime-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.
Sponsors
Julie Pendergast
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMatt Thomas, PhD
CONTACTJulie S Pendergast, PhD
PRINCIPAL_INVESTIGATORJulie Pendergast, PhD
University of Kentucky
Outcome results
None listed