NCT07203196

Circadian Health Regulation and Optimization for Rejuvenation Outcomes

Circadian Health Regulation and Optimization for Rejuvenation Outcomes: The CHRONO Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Salk Institute for Biological Studies · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Circadian Rhythm Optimization	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.

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-10-02
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States