Status:
ACTIVE_NOT_RECRUITING
Circadian Health Regulation and Optimization for Rejuvenation Outcomes
Lead Sponsor:
Salk Institute for Biological Studies
Collaborating Sponsors:
University of California, San Diego
Conditions:
Aging, Healthy
Blood Sugar; High
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07203196
Start Date
October 22 2025
End Date
April 1 2026
Last Update
December 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Diego
La Jolla, California, United States, 92037