Mild Cognitive ImpairmentPhase 1TREADNCT06548191
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
A Phase 1 study testing Time-restricted eating in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Alzheimer's Disease
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to 30 Jun 2027
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons, aged ≥60 years
- In good general health as evidenced by medical history or diagnosed with clinical diagnosis of MCI/AD: meeting research consensus criteria for probable MCI or dementia due to AD, requiring positive amyloid biomarkers in brain or cerebrospinal fluid (CSF) obtained at their regular point of care or study referral no longer than 3 months prior to screening.
- Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
- Daily night fasting <12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
- For cognitively normal living partners in the dyads group, scores >26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.
Who cannot join
- Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
- Presenting cognitive impairment not due to AD.
- Clinical diagnoses of diabetes.
- Actively using insulin in the past 6 months.
- Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
- Currently taking any medication known to affect appetite, inlcuding but not limited to GLP-1 agonists.
Show all 10Show fewer
- Any history of disordered eating, including difficulty swallowing and refusal to eat.
- Currently engaged in shift work.
- In treatment with another investigational drug.
- Body Mass Index (BMI) <20. or >35
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia Ott, M.S. contact
United States1 site, 1 recruiting
- Recruiting
Shiley Marcos Alzheimer's Disease Center
San Diego, California, 92093
Paula Desplats, TREAD@health.ucsd.edu
Paula Desplats, PhD
About this study
The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). It will also learn about the feasibility of practicing 14 h of nightly fasting in this group of older adults. The main questions it aims to answer are:
- Does prolonged nightly fasting of 14 h can reduce markers of AD pathology and aging and reduce cognitive and sleep alterations in MCI and AD patients?
- Can patients with MCI and early /moderate AD sustain time-restricted eating for 3 to 6 months? Researchers will compare participants who fast for 14 h per night during 3 months to those who fast for less than 12 h/night. Researchers will also compare participants that fast for 3 months to those who fast during 6 months, to determine the effective duration of the intervention. Finally, researchers will evaluate whether following the time-restricted eating diet alongside a partner actively following the same diet, will increase adherence to the protocol compared to subjects that fast alone.
Read more
Participants will:
- Fast for 14 h a night (stop eating at 8 pm and start eating the following morning at 10 am) for 3 or 6 months
- Visit the clinic three times (at the beginning of the study, 6 and 12 months later)
- Provide blood samples and take a cognitive test during clinic visits
- Keep a diary (or use an app on a smart phone) to record time of eating
- Wear an activity tracker watch
Read the detailed description
Study Description: Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimer's disease (AD) patients. The rationale for this proposal is that the prolonged nightly fasting form of Time-restricted eating (TRE) aligns food intake with the daytime "wake phase" of the biological clock, optimizing nutrient processing, and may modulate disease trajectory in AD. This Pilot study will test the feasibility and safety of TRE, consisting of 14 hours of night fasting for 3 or 6 months, in patients along the AD continuum and will explore the outcomes of this intervention on markers of aging and AD pathology. Results from this study will provide a strong scientific justification and will optimize the methods for a larger trial to determine the clinical efficacy of TRE to mitigate disease progression in AD and related dementias.
Objectives:
Primary Objective: Test the feasibility of a TRE intervention (TREAD) among patients with Mild Cognitive Impairment (MCI) or AD.
Secondary Objectives: Explore the effects of TRE on metabolic and pathological markers in MCI/AD patients.
Endpoints:
Primary Endpoint: Feasibility, safety, cognition, and metabolic indicators. Secondary Endpoints: Biomarkers of AD pathology, sleep and activity, and markers of epigenetic aging.
Study Population:
Adult subjects (female and males, ≥60 years old) with normal cognition or with a clinical diagnosis of MCI/AD (meeting research consensus criteria for probable MCI or dementia due to AD).
Phase: Early phase 1
Description of Sites/Facilities Enrolling Participants:
Shiley-Marcos Alzheimer's disease Research Center (SMARDC) at the University of California San Diego (UCSD) La Jolla campus.
Description of Study Intervention: The investigators will enroll older-adult participants (>60 years old) clinically diagnosed with MCI or early to moderate AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner (> 18 years old ); for a total enrollment of 60 subjects. All participants must have a baseline nightly fasting of <12 h. Individual participants and dyads will be randomized into the Intervention group (INT) or the Delayed Start Intervention group (DS-INT). The intervention will involve prolonged nightly fasting of 14 hours (TRE). The INT group will follow the TRE regimen for 12 months. The DS-INT group will practice their regular eating pattern for 3 months (nightly fasting <12 h) followed by 3 months of TRE. All participants will have study visits, outcome assessments, and biospecimen collections at baseline, 3, and 6 months.
Study Duration: Two years Participant Duration: 6 months
- Being tested
- Time-restricted eating
- Keywords
- Time-Restricted Eating, Intermittent Fasting, Prolonged Nightly Fasting, Mild Cognitive Impairment, Alzheimer Disease, Circadian Rhythms, Cognition, Neuropathology
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Also called Prolonged Nightly Fasting
Fasting (abstinence from calorie-containing food or drink) during 14 h at night, with no caloric consumption after 8 pm to align with circadian rhythms
| Study group | Role | What they receive |
|---|---|---|
| Delayed-Start Intervention | Active comparator | Participants will continue their regular eating schedule (nightly fasting for less than 12 h) during the first 3 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 3 months. Receives: Behavioral: Time-restricted eating |
| Intervention | Active comparator | Participants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months. Receives: Behavioral: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
Test the feasibility of a Time-restricted eating intervention in patients with MCI or AD by quantification the number of days during the intervention period when the particpants reached the goal intervention fasting time of 14 h, b) increased fasting of >12 h and <14 h.
Measured: 3 and 6 months
Secondary outcomes (9)
Effects of TRE on activity rhythms measured as steps/day using an accelerometer
The investigators will measure the participants' 24-hour activity rhythms using an actigraph unit. The investigators will calculate interday stability and intraday variability of activity rhythms, which have been reported as sensitive in studies on aging and AD cohorts. Interday stability will indicate the stability of rhythms across several days. Intraday variability will indicate the fragmentation of rhythms.
Measured: baseline, 3 and 6 months
Effects of TRE on skin temperature rhythms measured in F using a smart sensor.
The investigators will measure the participants' 24-hour temperature rhythms using a smart sensor. The investigators will calculate interday stability and intraday variability of skin temperature as a circadian output.
Measured: baseline, 3 and 6 months
Effects of TRE on sleep quantity (as hours/night) using a smart sensor.
The investigators will determine changes in sleep duration during the study as recorded by a smart sensor and accessed via the Fitabase.
Measured: Baseline, 3 and 6 months
Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.
The investigators will determine whether the overall sleep efficiency changes based on the sleep score calculated based on metrics collected with the accelerometer watch. The overall sleep score is a sum of the individual scores in sleep duration, sleep quality, and restoration, with a maximum of 100. Sleep score tiers are: Excellent: 90-100; Good: 80-89; Fair: 60-79; Poor: Less than 60.
Measured: baseline, 3 and 6 months
Explore the effects of TRE on pathology in MCI/AD patients
Evaluate levels of amyloid Beta (AB)40, AB42, phospho-Tau181, Neurofilament light chain protein, and markers of neuroinflammation in plasma
Measured: baseline, 3 and 6 months
Explore the effects of TRE on markers of epigenetic aging by profiling DNA methylation in blood samples.
The investigators will profile genome-wide DNA methylation in whole blood using the Infinium Methylation EPIC v2.0 array (Illumina) to determine whether prolonged fasting modulates epigenetic aging rates. A beneficial effect will result in no changes to the subjects' biological aging rate or a deacceleration of aging.
Measured: baseline, 3 and 6 months
Explore the effects of TRE on fasting blood glucose (mg/mL)
The investigators will measure glucose levels in the blood at the end of fasting during the clinical visits to evaluate whether prolonged fasting reduces fasting glucose as an indicator of metabolic health.
Measured: baseline, 3 and 6 months
Evaluation of neurocognitive changes using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
The investigators will utilize the ADAS-Cog test to investigate whether TRE reduces cognitive decline in MCI and AD patients, expressed as the average score changes between visits. The ADAS-Cog is a brief neuropsychological assessment tool used to determine the severity of cognitive symptoms of dementia, widely used in clinical trials assessing antidementia treatments. The ADAS-Cog scores range from 0 to 70, with higher scores indicating poorer performance. It consists of 11 tasks, including Word Recall, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition, Remembering Test Directions, Spoken Language, Comprehension, and Word-Finding Difficulty.
Measured: baseline and 6 months
Evaluation of changes in self-reported sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
The investigators will utilize the PSQI to investigate whether TRE improves self-reported sleep quality. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the worst dysfunction. The global PSQI score ranges from 0 to 21 and is obtained by adding the scores of the seven components of the test. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start23 Apr 2025
- Primary completion30 Apr 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.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- TREAD will enroll 40 older adults (60+ years) with cognitive impairment and clinically diagnosed with Mild Cognitive Impairment (MCI) or early to moderate AD; and 20 cognitively normal subjects (18+ years). The investigators will recruit individual participants with a diagnosis of MCI/AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner. This design is necessary to evaluate how feasible and burdensome is to follow a time-restricted eating pattern for individuals with cognitive impairment. Individual and dyad participants will be randomized in equal ratios to the complete prolonged nightly fasting intervention (14 h fast with no energy intake after 8 pm for 6 months) or to a delayed-start prolonged nightly fasting intervention (3 initial months of unrestricted eating patterns followed by 3 months of 14 h fast with no energy intake after 8 pm) using a random permuted-block design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Paula Desplats, University of California, San Diego
- Investigators
- Paula Desplats, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548191
- Sponsor's protocol ID
- RD10061932
- Other IDs
- R61AG085253
- Acronym
- TREAD
- Status last verified
- May 2026
- First submitted
- 20 Jul 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06548191
- Acronym / sponsor ID
- TREAD / RD10061932
- Keywords
- Time-Restricted Eating, Intermittent Fasting, Prolonged Nightly Fasting, Mild Cognitive Impairment, Alzheimer Disease, Circadian Rhythms, Cognition, Neuropathology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2024 (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.
The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). It will also learn about the feasibility of practicing 14 h of nightly fasting in this group of older adults. The main questions it aims to answer are:
- Does prolonged nightly fasting of 14 h can reduce markers of AD pathology and aging and reduce cognitive and sleep alterations in MCI and AD patients?
- Can patients with MCI and early /moderate AD sustain time-restricted eating for 3 to 6 months? Researchers will compare participants who fast for 14 h per night during 3 months to those who fast for less than 12 h/night. Researchers will also compare participants that fast for 3 months to those who fast during 6 months, to determine the effective duration of the intervention. Finally, researchers will evaluate whether following the time-restricted eating diet alongside a partner actively following the same diet, will increase adherence to the protocol compared to subjects that fast alone.
Participants will:
- Fast for 14 h a night (stop eating at 8 pm and start eating the following morning at 10 am) for 3 or 6 months
- Visit the clinic three times (at the beginning of the study, 6 and 12 months later)
- Provide blood samples and take a cognitive test during clinic visits
- Keep a diary (or use an app on a smart phone) to record time of eating
- Wear an activity tracker watch
Detailed description
Study Description: Our overarching hypothesis is that circadian alignment of food intake and biological clocks can reduce pathology and improve cognitive function in Alzheimer's disease (AD) patients. The rationale for this proposal is that the prolonged nightly fasting form of Time-restricted eating (TRE) aligns food intake with the daytime "wake phase" of the biological clock, optimizing nutrient processing, and may modulate disease trajectory in AD. This Pilot study will test the feasibility and safety of TRE, consisting of 14 hours of night fasting for 3 or 6 months, in patients along the AD continuum and will explore the outcomes of this intervention on markers of aging and AD pathology. Results from this study will provide a strong scientific justification and will optimize the methods for a larger trial to determine the clinical efficacy of TRE to mitigate disease progression in AD and related dementias.
Objectives:
Primary Objective: Test the feasibility of a TRE intervention (TREAD) among patients with Mild Cognitive Impairment (MCI) or AD.
Secondary Objectives: Explore the effects of TRE on metabolic and pathological markers in MCI/AD patients.
Endpoints:
Primary Endpoint: Feasibility, safety, cognition, and metabolic indicators. Secondary Endpoints: Biomarkers of AD pathology, sleep and activity, and markers of epigenetic aging.
Study Population:
Adult subjects (female and males, ≥60 years old) with normal cognition or with a clinical diagnosis of MCI/AD (meeting research consensus criteria for probable MCI or dementia due to AD).
Phase: Early phase 1
Description of Sites/Facilities Enrolling Participants:
Shiley-Marcos Alzheimer's disease Research Center (SMARDC) at the University of California San Diego (UCSD) La Jolla campus.
Description of Study Intervention: The investigators will enroll older-adult participants (>60 years old) clinically diagnosed with MCI or early to moderate AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner (> 18 years old ); for a total enrollment of 60 subjects. All participants must have a baseline nightly fasting of <12 h. Individual participants and dyads will be randomized into the Intervention group (INT) or the Delayed Start Intervention group (DS-INT). The intervention will involve prolonged nightly fasting of 14 hours (TRE). The INT group will follow the TRE regimen for 12 months. The DS-INT group will practice their regular eating pattern for 3 months (nightly fasting <12 h) followed by 3 months of TRE. All participants will have study visits, outcome assessments, and biospecimen collections at baseline, 3, and 6 months.
Study Duration: Two years Participant Duration: 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- TREAD will enroll 40 older adults (60+ years) with cognitive impairment and clinically diagnosed with Mild Cognitive Impairment (MCI) or early to moderate AD; and 20 cognitively normal subjects (18+ years). The investigators will recruit individual participants with a diagnosis of MCI/AD (n=20 subjects) and 20 dyads of participants (n=40 subjects) composed of an MCI/AD patient and a cognitively normal living partner. This design is necessary to evaluate how feasible and burdensome is to follow a time-restricted eating pattern for individuals with cognitive impairment. Individual and dyad participants will be randomized in equal ratios to the complete prolonged nightly fasting intervention (14 h fast with no energy intake after 8 pm for 6 months) or to a delayed-start prolonged nightly fasting intervention (3 initial months of unrestricted eating patterns followed by 3 months of 14 h fast with no energy intake after 8 pm) using a random permuted-block design.
| Arm | Type | Receives |
|---|---|---|
| Delayed-Start Intervention | Active comparator | Behavioral: Time-restricted eatingParticipants will continue their regular eating schedule (nightly fasting for less than 12 h) during the first 3 months and start time-restricted eating intervention ( 14 h of nightly fasting) for the next 3 months. |
| Intervention | Active comparator | Behavioral: Time-restricted eatingParticipants will follow the time-restricted regimen (14 h of nightly fasting) for 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persons, aged ≥60 years
- In good general health as evidenced by medical history or diagnosed with clinical diagnosis of MCI/AD: meeting research consensus criteria for probable MCI or dementia due to AD, requiring positive amyloid biomarkers in brain or cerebrospinal fluid (CSF) obtained at their regular point of care or study referral no longer than 3 months prior to screening.
- Ability and willingness to complete cognitive evaluations, blood draw, actigraphy monitoring and to record fasting times daily.
- Daily night fasting <12h at baseline. Ability and willingness to follow an eating protocol of prolonged night fasting for 14 h
- For cognitively normal living partners in the dyads group, scores >26 in the Montreal Cognitive Assessment (MoCA) test administered at screening.
Key exclusion criteria (10 listed)
- Clinical diagnosis with a neurodegenerative condition other than MCI/AD.
- Presenting cognitive impairment not due to AD.
- Clinical diagnoses of diabetes.
- Actively using insulin in the past 6 months.
- Started a new medication (or changed doses) indicated for the treatment of MCI/AD in the last three months prior to enrollment.
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 eatingAlso: Prolonged Nightly FastingFasting (abstinence from calorie-containing food or drink) during 14 h at night, with no caloric consumption after 8 pm to align with circadian rhythms | Behavioural | Delayed-Start Intervention, Intervention |
Primary outcome
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h.
Time frame: 3 and 6 months
Test the feasibility of a Time-restricted eating intervention in patients with MCI or AD by quantification the number of days during the intervention period when the particpants reached the goal intervention fasting time of 14 h, b) increased fasting of >12 h and <14 h.
9 secondary outcomes
Effects of TRE on activity rhythms measured as steps/day using an accelerometer
Time frame: baseline, 3 and 6 months
Effects of TRE on skin temperature rhythms measured in F using a smart sensor.
Time frame: baseline, 3 and 6 months
Effects of TRE on sleep quantity (as hours/night) using a smart sensor.
Time frame: Baseline, 3 and 6 months
Effects of TRE on sleep quality (determined by a sleep score) using a smart sensor.
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on pathology in MCI/AD patients
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on markers of epigenetic aging by profiling DNA methylation in blood samples.
Time frame: baseline, 3 and 6 months
Explore the effects of TRE on fasting blood glucose (mg/mL)
Time frame: baseline, 3 and 6 months
Evaluation of neurocognitive changes using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
Time frame: baseline and 6 months
Evaluation of changes in self-reported sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: baseline, 3 and 6 months
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 26 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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.
Olivia Ott, M.S. contact
Paula Desplats, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Time-restricted eating in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of California, San Diego 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 5 inclusion and 10 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 26 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Paula Desplats, PhD (858-534-4839, pdesplat@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: assessed by computing the number of nights achieving the goal fasting time of 14 h. (time frame: 3 and 6 months). 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 26 May 2026.