Aging, HealthyCHRONONCT07203196
Circadian Health Regulation and Optimization for Rejuvenation Outcomes
A study testing Circadian Rhythm Optimization in people with Aging, Healthy and Blood Sugar; High, run by Salk Institute for Biological Studies at 1 site in United States.
Trial summary
In this single arm intervention trial, the investigators will assess the impact of a personalized lifestyle plan, centered on supporting biological rhythms, on blood sugar levels, physical, cognitive and immune function in older adults with a habitual eating window of 12 hours or more, and elevated blood glucose… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Aging, Healthy, Blood Sugar; High, Blood Sugar (Glucose) Control
- What is being tested?
- Circadian Rhythm Optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to 1 Apr 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50-80 years
- Fasting glucose ≥ 100 mg/dL or HbA1c > 5.6%
- Own a smartphone (Apple iOS or Android OS)
- Proficient in reading and speaking in English
- An eating window ≥12 hour/day
- Willing to travel to sports facilities for exercise training sessions
- Participants on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, SLGT2 inhibitors, GLP1 receptor agonists other lipid-modifying drugs (including over-the counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are allowed if on a stable dose for 6-months, but dose adjustments are not allowed during the study
Who cannot join
- Insufficient dietary logging on the mCC app during screening, defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes
- HbA1C > 9.0%
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Change in medications that could impact study outcomes within the past 6 months
- Change in weight of >4kg in the past 3 months
Show all 31Show fewer
- Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
- Fasting LDL cholesterol greater than 250 mg/dL
- Fasting triglycerides greater than 500g/dL
- Variable work hours, such as working night shifts
- Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions
- Active tobacco use, illicit drug use, or history of treatment for alcohol abuse in the past 5 years.
- Travel involving a time zone change of more than 3 hours twice or more during the study period
- Active treatment for inflammatory and/or rheumatologic disease
- History of a major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack)
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are acceptable)
- Previously diagnosed with sever aortic stenosis
- Previously diagnosed with sever COPD (FEV1/FVC ratio <.7 \& FEV1 (%predicted) <49
- Orthopedic impairments severely compromising exercise performance
- BMI <18.5 kg/m2
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 6 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- History of adrenal disease in the past 5 years
- History of malignancy undergoing active treatment, except non-melanoma skin cancer, in the past 5 years
- History of an eating disorder in the past 5 years
- History of cirrhosis in the past 5 years
- History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
- History of HIV/AIDs
- Currently enrolled in weight-loss or weight-management program
- Regularly engages in 100 minutes or more of structured exercise
- VO2 max threshold is above average for that individuals age group [78]
- Uncontrolled psychiatric disorder including prior hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
Official title: Circadian Health Regulation and Optimization for Rejuvenation Outcomes: The CHRONO Study
In this single arm intervention trial, the investigators will assess the impact of a personalized lifestyle plan, centered on supporting biological rhythms, on blood sugar levels, physical, cognitive and immune function in older adults with a habitual eating window of 12 hours or more, and elevated blood glucose levels.
All participants will be provided with a personalized circadian rhythm optimization plan (CRO) centered on improving (1) diet, (2) exercise (3) sleep habits based on their body's natural rhythms. The study includes a 2-week screening/baseline assessments, with follow-up health assessments at 2-months.
Read the detailed description
The purpose of this study is to assess if modifying lifestyle behaviors such as improving nutrition quality while consolidating caloric intake to a consistent 8-10 hour window, incorporating regular exercise and ensuring a consistent sleep window will help improve glucose (sugar) regulation, physical, cognitive and immune function and improve other markers of metabolic, cardiovascular health and aging (i.e. lipid levels, inflammation markers, etc.).
Circadian clocks ("circa" means approximately and "dia" means day) are daily rhythms in physiology and behavior (activity, sleep, eating pattern) that help the body anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and almost every organ. Remarkably, even in the absence of any timing information from a device, the human body can keep track of time and thereby help us eat and sleep at optimum times. However, our lifestyle and work schedules can lead us to eat, exercise, and sleep at times that the clocks in our body are not prepared for. When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including increased body weight, poor sleep, and elevated risk for various chronic diseases.
A growing body of preclinical research has shown that synchronizing behaviors, such as food intake, exercise, and light exposure, with the body's biological clock improves skeletal muscle function, cognitive performance, and inflammatory markers. Clinical studies have further validated these findings, showing that circadian-based interventions, such as time-restricted eating (TRE), which restricts all caloric intake to a personalized consistent daily eating window, daytime light exposure and exercise have been shown to improve mood, sleep quality and cardiometabolic health. Despite these promising individual findings, no study has comprehensively examined the combined effects of TRE, structured exercise and optimized sleep schedule as an integrated strategy to restore circadian alignment and reverse key physiological markers of aging in older adults.
In this study, the investigators are interested in evaluating the effects of modifying eating, activity and sleeping patterns on age related health outcomes in older adults with elevated blood sugar levels. All participants will be provided with a personalized circadian rhythm optimization (CRO) program centered on (1) consuming a Mediterranean diet within a personalized 8-10-hour daytime window, (2) increasing daytime light exposure and reducing bright light at night, (3) incorporating 150 minutes of moderate-intensity aerobic exercise each week (4) holding a consistent 7-9 hour sleep schedule (5) taking supplements based on individual needs.
The study is 90-days including a 2-week screening/baseline assessment followed by a 2-week period to developed their personalized plan based off their baseline assessments and finally a 8-week guided intervention period. Health assessments will be taken at screening/baseline, and at 90 days. Assessments will include cognitive function (cognitive assessment battery), physical function (VO2 Max, isometric strength, short physical performance battery), dietary recall (ASA24), blood tests (biomarkers of cardiometabolic health and immune parameters), glycemic regulation (Continuous Glucose Monitors), body composition ( bioelectrical impedance scan), dietary intake (logged on the myCircadianClock smartphone app), sleep and quality of life questionnaires, and activity, sleep, and wrist temperature (actigraphy watch) and subclavian and ankle surface temperature (non-invasive temperature sensor).
- Conditions
- Aging, Healthy, Blood Sugar; High, Blood Sugar (Glucose) Control, Time Restricted Eating, Circadian Dysregulation
- Being tested
- Circadian Rhythm Optimization
- Keywords
- Time restricted eating, healthy aging, circadian disruption
- Medical subject headings
- Hyperglycemia, Intermittent Fasting, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Rhythm OptimizationBehavioural
Participants will follow a Mediterranean diet while consuming all calories within a personalized 8-10 hour daytime window. They will increase daytime light exposure to at least one hour per day, engage in a minimum of 150 minutes of moderate-intensity aerobic exercise each week (including at least two sessions lasting no less than 60 minutes), maintain a consistent 7-9 hour sleep schedule, and take supplements as recommended based on individual needs. Participants will also record all food and beverage intake, as well as exercise, using the myCircadianClock app.
| Study group | Role | What they receive |
|---|---|---|
| Circadian Rhythm Optimization | Experimental | Each participant will be provided with a personalized plan centered on synchronizing their behavior with their endogenous rhythm. Receives: Behavioral: Circadian Rhythm Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (%)
HbA1c levels (%) as assessed by fasting blood draw
Measured: Baseline and 90 days
Secondary outcomes (58)
Grip Strength
Maximal grip force (Kg)
Measured: Baseline and 90 days
Isometric Knee Strength
Maximal force output for knee flexion and extension (Kg)
Measured: Baseline and 90 days
VO2 Max
Maximal oxygen consumption (mL/kg/min).
Measured: Baseline and 90 days
Time to 85% of Age Predicted Maximal Heart Rate
Time to 85% of age predicted maximal heart rate (mins).
Measured: Baseline and 90 days
Flanker Inhibitory and Control and Attention Test (Fully-Corrected T-score)
Flanker Inhibitory and Control and Attention Test (Fully-Corrected T-score) assessed through NIH cognitive assessment battery. The score compares an individual's cognitive performance to a nationally representative norming sample correcting for age, sex, race/ethnicity, and educational attainment.
Measured: Baseline and 90 days
Dimensional Change Card Sort (Fully-Corrected T-score)
Dimensional Change Card Sort (Fully-Corrected T-score) assessed through NIH cognitive assessment battery. The score compares an individual's cognitive performance to a nationally representative norming sample correcting for age, sex, race/ethnicity, and educational attainment.
Measured: Baseline and 90 days
Pattern Comparison Processing Speed Test (Fully-Corrected T-score)
Pattern Comparison Processing Speed Test (Fully-Corrected T-score) assessed through NIH cognitive assessment battery. The score compares an individual's cognitive performance to a nationally representative norming sample correcting for age, sex, race/ethnicity, and educational attainment.
Measured: Baseline and 90 days
Picture Sequence Memory test (Fully-Corrected T-score)
Picture Sequence Memory test (Fully-Corrected T-score) assessed through NIH cognitive assessment battery. The score compares an individual's cognitive performance to a nationally representative norming sample correcting for age, sex, race/ethnicity, and educational attainment.
Measured: Baseline and 90 days
Trail Making Test
Trail making test part A and B will be assessed by the time to completion (seconds) for each assessment.
Measured: Baseline and 90 days
Glucagon (pg/mL)
Glucagon (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
Leptin (ng/mL)
Leptin (ng/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-1α (pg/mL)
IL-1α (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-1β (pg/mL)
IL-1β (pg/mL)assessed through fasting blood draw
Measured: Baseline and 90 days
IL-2 (pg/mL)
IL-2 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-3 (pg/mL)
IL-3 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-4 (pg/mL)
IL-4 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-5 (pg/mL)
IL-5 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-6 (pg/mL)
IL-6 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-7 (pg/mL)
IL-7 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-8
IL-8 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-9 (pg/mL)
IL-9 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-10 (pg/mL)
IL-10 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-12p70 (pg/mL)
IL-12p70 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-13 (pg/mL)
IL-13 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-15 (pg/mL)
IL-15 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-16 (pg/mL)
IL-16 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-17A (pg/mL)
IL-17A (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-17F (pg/mL)
IL-17F (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-18 (pg/mL)
IL-18 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90-days
IL-20 (pg/mL)
IL-20 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-21 (pg/mL)
IL-21 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-22 (pg/mL)
IL-22 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-23 (pg/mL)
IL-23 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-27 (pg/mL)
IL-27 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-28 (pg/mL)
IL-28 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-33 (pg/mL)
IL-33 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
MCP-1 (pg/mL)
MCP-1 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
MCP-2
MCP-2 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
MCP-3 (pg/mL)
MCP-3 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
MCP-4 (pg/mL)
MCP-4 (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
TGFα (pg/mL)
TGFα (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
TNFβ (pg/mL)
TNFβ (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
EGF (pg/mL)
EGF (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
TNF-α (pg/mL)
TNF-α (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
Ghrelin (pg/mL)
Ghrelin (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90-days
IGF-1 (ng/mL)
IGF-1 (ng/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IGF-2 (ng/mL)
IGF-2 (ng/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IL-1RA (pg/mL)
IL-1RA (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
TRAIL (pg/mL)
TRAIL (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
VEGF-A (pg/mL)
VEGF-A (pg/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
IGFBP-1 (ug/mL)
IGFBP-1 (ug/mL) assessed through fasting blood draw
Measured: Baseline and 90 days
GIP (pg/mL)
GIP(pg/mL) assessed through fasting blood draw
Measured: Baseline and 90-days
GLP-1 (pmol/L)
GLP-1 (pmol/L) assessed through fasting blood draw.
Measured: Baseline and 90 days
Total Recall (T-score)
Total Recall (T-score) as assessed through Hopkins Verbal Learning Test - Revised. T-score is adjusted for participant's age.
Measured: Baseline and 90-days
Delayed Recall (T-score)
Delayed Recall (T-score) as assessed through Hopkins Verbal Learning Test. T-score is adjusted for participant's age.
Measured: Baseline and 90-days
Retention Percentage (T-score)
Retention Percentage (T-score) as assessed through Hopkins Verbal Learning Test - Revised. T-score is adjusted for participant's age.
Measured: Baseline and 90-days
Recognition Discrimination Index (T-score)
Recognition discrimination index as assessed through Hopkins Verbal Learning Test-Revised. T-score is adjusted for participant's age.
Measured: Baseline and 90-days
Cognition Fluid Composite (Fully-Corrected T-score)
Cognition Fluid Composite (Fully-Corrected T-score) as assessed through a composite score of several tests, namely the Flanker inhibitory control and attention test, the dimensional change card sort test, the picture sequence memory test, the list sorting working memory test, and the pattern comparison processing speed test. The score compares an individual's cognitive performance to a nationally representative norming sample correcting for age, sex, race/ethnicity, and educational attainment.
Measured: Baseline and 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start22 Oct 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salk Institute for Biological Studies
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Satchidananda Panda, PhD, Salk Institute for Biological Studies
- Investigators
- Satchidananda Panda, PhD, Principal investigator, Salk Institute for Biological StudiesPam Taub, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203196
- Sponsor's protocol ID
- 812811
- Acronym
- CHRONO
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Health Regulation and Optimization for Rejuvenation Outcomes: The CHRONO Study
- ClinicalTrials.gov ID
- NCT07203196
- Acronym / sponsor ID
- CHRONO / 812811
- Conditions
- Aging, Healthy, Blood Sugar; High, Blood Sugar (Glucose) Control, Time Restricted Eating, Circadian Dysregulation
- Keywords
- Time restricted eating, healthy aging, circadian disruption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Salk Institute for Biological StudiesUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
In this single arm intervention trial, the investigators will assess the impact of a personalized lifestyle plan, centered on supporting biological rhythms, on blood sugar levels, physical, cognitive and immune function in older adults with a habitual eating window of 12 hours or more, and elevated blood glucose levels.
All participants will be provided with a personalized circadian rhythm optimization plan (CRO) centered on improving (1) diet, (2) exercise (3) sleep habits based on their body's natural rhythms. The study includes a 2-week screening/baseline assessments, with follow-up health assessments at 2-months.
Detailed description
The purpose of this study is to assess if modifying lifestyle behaviors such as improving nutrition quality while consolidating caloric intake to a consistent 8-10 hour window, incorporating regular exercise and ensuring a consistent sleep window will help improve glucose (sugar) regulation, physical, cognitive and immune function and improve other markers of metabolic, cardiovascular health and aging (i.e. lipid levels, inflammation markers, etc.).
Circadian clocks ("circa" means approximately and "dia" means day) are daily rhythms in physiology and behavior (activity, sleep, eating pattern) that help the body anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and almost every organ. Remarkably, even in the absence of any timing information from a device, the human body can keep track of time and thereby help us eat and sleep at optimum times. However, our lifestyle and work schedules can lead us to eat, exercise, and sleep at times that the clocks in our body are not prepared for. When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including increased body weight, poor sleep, and elevated risk for various chronic diseases.
A growing body of preclinical research has shown that synchronizing behaviors, such as food intake, exercise, and light exposure, with the body's biological clock improves skeletal muscle function, cognitive performance, and inflammatory markers. Clinical studies have further validated these findings, showing that circadian-based interventions, such as time-restricted eating (TRE), which restricts all caloric intake to a personalized consistent daily eating window, daytime light exposure and exercise have been shown to improve mood, sleep quality and cardiometabolic health. Despite these promising individual findings, no study has comprehensively examined the combined effects of TRE, structured exercise and optimized sleep schedule as an integrated strategy to restore circadian alignment and reverse key physiological markers of aging in older adults.
In this study, the investigators are interested in evaluating the effects of modifying eating, activity and sleeping patterns on age related health outcomes in older adults with elevated blood sugar levels. All participants will be provided with a personalized circadian rhythm optimization (CRO) program centered on (1) consuming a Mediterranean diet within a personalized 8-10-hour daytime window, (2) increasing daytime light exposure and reducing bright light at night, (3) incorporating 150 minutes of moderate-intensity aerobic exercise each week (4) holding a consistent 7-9 hour sleep schedule (5) taking supplements based on individual needs.
The study is 90-days including a 2-week screening/baseline assessment followed by a 2-week period to developed their personalized plan based off their baseline assessments and finally a 8-week guided intervention period. Health assessments will be taken at screening/baseline, and at 90 days. Assessments will include cognitive function (cognitive assessment battery), physical function (VO2 Max, isometric strength, short physical performance battery), dietary recall (ASA24), blood tests (biomarkers of cardiometabolic health and immune parameters), glycemic regulation (Continuous Glucose Monitors), body composition ( bioelectrical impedance scan), dietary intake (logged on the myCircadianClock smartphone app), sleep and quality of life questionnaires, and activity, sleep, and wrist temperature (actigraphy watch) and subclavian and ankle surface temperature (non-invasive temperature sensor).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circadian Rhythm Optimization | Experimental | Behavioral: Circadian Rhythm OptimizationEach participant will be provided with a personalized plan centered on synchronizing their behavior with their endogenous rhythm. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 50-80 years
- Fasting glucose ≥ 100 mg/dL or HbA1c > 5.6%
- Own a smartphone (Apple iOS or Android OS)
- Proficient in reading and speaking in English
- An eating window ≥12 hour/day
Key exclusion criteria (31 listed)
- Insufficient dietary logging on the mCC app during screening, defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes
- HbA1C > 9.0%
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Change in medications that could impact study outcomes within the past 6 months
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 |
|---|---|---|
| Circadian Rhythm OptimizationParticipants will follow a Mediterranean diet while consuming all calories within a personalized 8-10 hour daytime window. They will increase daytime light exposure to at least one hour per day, engage in a minimum of 150 minutes of moderate-intensity aerobic exercise each week (including at least two sessions lasting no less than 60 minutes), maintain a consistent 7-9 hour sleep schedule, and take supplements as recommended based on individual needs. Participants will also record all food and beverage intake, as well as exercise, using the myCircadianClock app. | Behavioural | Circadian Rhythm Optimization |
Primary outcome
HbA1c (%)
Time frame: Baseline and 90 days
HbA1c levels (%) as assessed by fasting blood draw
58 secondary outcomes
Grip Strength
Time frame: Baseline and 90 days
Isometric Knee Strength
Time frame: Baseline and 90 days
VO2 Max
Time frame: Baseline and 90 days
Time to 85% of Age Predicted Maximal Heart Rate
Time frame: Baseline and 90 days
Flanker Inhibitory and Control and Attention Test (Fully-Corrected T-score)
Time frame: Baseline and 90 days
Dimensional Change Card Sort (Fully-Corrected T-score)
Time frame: Baseline and 90 days
Pattern Comparison Processing Speed Test (Fully-Corrected T-score)
Time frame: Baseline and 90 days
Picture Sequence Memory test (Fully-Corrected T-score)
Time frame: Baseline and 90 days
Trail Making Test
Time frame: Baseline and 90 days
Glucagon (pg/mL)
Time frame: Baseline and 90 days
Leptin (ng/mL)
Time frame: Baseline and 90 days
IL-1α (pg/mL)
Time frame: Baseline and 90 days
IL-1β (pg/mL)
Time frame: Baseline and 90 days
IL-2 (pg/mL)
Time frame: Baseline and 90 days
IL-3 (pg/mL)
Time frame: Baseline and 90 days
IL-4 (pg/mL)
Time frame: Baseline and 90 days
IL-5 (pg/mL)
Time frame: Baseline and 90 days
IL-6 (pg/mL)
Time frame: Baseline and 90 days
IL-7 (pg/mL)
Time frame: Baseline and 90 days
IL-8
Time frame: Baseline and 90 days
IL-9 (pg/mL)
Time frame: Baseline and 90 days
IL-10 (pg/mL)
Time frame: Baseline and 90 days
IL-12p70 (pg/mL)
Time frame: Baseline and 90 days
IL-13 (pg/mL)
Time frame: Baseline and 90 days
IL-15 (pg/mL)
Time frame: Baseline and 90 days
IL-16 (pg/mL)
Time frame: Baseline and 90 days
IL-17A (pg/mL)
Time frame: Baseline and 90 days
IL-17F (pg/mL)
Time frame: Baseline and 90 days
IL-18 (pg/mL)
Time frame: Baseline and 90-days
IL-20 (pg/mL)
Time frame: Baseline and 90 days
IL-21 (pg/mL)
Time frame: Baseline and 90 days
IL-22 (pg/mL)
Time frame: Baseline and 90 days
IL-23 (pg/mL)
Time frame: Baseline and 90 days
IL-27 (pg/mL)
Time frame: Baseline and 90 days
IL-28 (pg/mL)
Time frame: Baseline and 90 days
IL-33 (pg/mL)
Time frame: Baseline and 90 days
MCP-1 (pg/mL)
Time frame: Baseline and 90 days
MCP-2
Time frame: Baseline and 90 days
MCP-3 (pg/mL)
Time frame: Baseline and 90 days
MCP-4 (pg/mL)
Time frame: Baseline and 90 days
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 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Investigators will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Satchidananda Panda, PhD principal investigator
Salk Institute for Biological Studies
Pam Taub, MD 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 study testing Circadian Rhythm Optimization in people with Aging, Healthy and Blood Sugar; High, run by Salk Institute for Biological Studies 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 7 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (%) (time frame: Baseline and 90 days). 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 31 Dec 2025.