Circadian Health Regulation and Optimization for Rejuvenation Outcomes

NCT07203196 | Active Not Recruiting

• 1 other identifier: 812811
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Time Restricted Eating; Circadian Dysregulation; Aging, Healthy; Blood Sugar; High; Blood Sugar (Glucose) Control

Keywords

Time restricted eating; healthy aging; circadian disruption

Outcome Measures

Primary Outcomes (1)

• HbA1c (%)

  HbA1c levels (%) as assessed by fasting blood draw

  Baseline and 90 days

Secondary Outcomes (58)

• Grip Strength

  Baseline and 90 days

• Isometric Knee Strength

  Baseline and 90 days

• VO2 Max

  Baseline and 90 days

• Time to 85% of Age Predicted Maximal Heart Rate

  Baseline and 90 days

• Flanker Inhibitory and Control and Attention Test (Fully-Corrected T-score)

  Baseline and 90 days

Other Outcomes (28)

• Total Body Fat Mass (kg)

  Baseline and 90 days

• Fat Free Mass

  Baseline and 90 days

• Intra-Daily Glycemic Variability: CONGA (A.U.)

  Baseline and 90-days

Study Arms (1)

Circadian Rhythm Optimization

EXPERIMENTAL

Each participant will be provided with a personalized plan centered on synchronizing their behavior with their endogenous rhythm.

Behavioral: Circadian Rhythm Optimization

Interventions

Circadian Rhythm Optimization BEHAVIORAL

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.

Circadian Rhythm Optimization

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Salk Institute for Biological Studies: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Intermittent Fasting; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior; Nervous System Diseases

Study Officials

• Satchidananda Panda, PhD

  Salk Institute for Biological Studies

  PRINCIPAL INVESTIGATOR

• Pam Taub, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 2, 2025
• Study Start: October 22, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 1 month of publication with no set end date (minimum of 5 years).
• Access Criteria: Data will be available to anyone who wants to access it through a data depository that will be disclosed at the time of publication.

Locations

US (1)