Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-restricted eating.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: 45 years — 95 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Number of participants adhering to TRE protocol [Time frame: From enrollment to study completion up to approximately 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT05858008 · 81627 · 3R01DK124774-03S1