Mild Cognitive ImpairmentNCT05858008
Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
A study testing Time-restricted eating in people with Mild Cognitive Impairment, run by Julie Pendergast at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 95 years, women only
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal Women
- Age 45-95
- Diagnosis of mild cognitive impairment
Who cannot join
- 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
Show all 9Show fewer
- Shift work or irregular lifestyle
- Diagnosed clinical eating disorder
- Participating in a formal weight loss program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Matt Thomas, PhD, (859) 218-6770, jmthomg@uky.edu
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Time-restricted eating
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | 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. Receives: Behavioral: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to study completion up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Apr 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie Pendergast
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Pendergast, University of Kentucky
- Investigators
- Julie Pendergast, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858008
- Sponsor's protocol ID
- 81627
- Other IDs
- 3R01DK124774-03S1
- Status last verified
- Jun 2026
- First submitted
- 4 May 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05858008
- Acronym / sponsor ID
- 81627
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Julie PendergastUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingParticipants 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. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal Women
- Age 45-95
- Diagnosis of mild cognitive impairment
Key exclusion criteria (9 listed)
- Individuals prone to hypoglycemia
- Liver disease
- Taking medications that affect eating behaviors
- Alcohol consumption of >2 drinks per day
- Significant circadian disruption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingSubjects 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. | Behavioural | Time-restricted eating |
Primary outcome
Number of participants adhering to TRE protocol
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Pendergast, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Mild Cognitive Impairment, run by Julie Pendergast at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Thomas, PhD ((859) 218-6770, jmthomg@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants adhering to TRE protocol (time frame: From enrollment to study completion up to approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.