Circadian Health Regulation and Optimization for Rejuvenation Outcomes (NCT07203196) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Circadian Health Regulation and Optimization for Rejuvenation Outcomes
United States16 participantsStarted 2025-10-22
Plain-language 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 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest