Recruiting

Chrononutrition

Sponsor:

Salk Institute for Biological Studies

Code:

NCT06891352

Conditions

Night Shift Work

Time Restricted Eating

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Dietary Monitoring

Time-Restricted Eating (TRE)

Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)

Study Details

Brief summary:

In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.

Conditions

Night Shift Work

Time Restricted Eating

Overweight

Obesity

Study ID

NCT06891352

Start date

Jun 2, 2025

Status verified date

Dec, 2025

Completion date

Mar 3, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 18-70 years
  • BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
  • Own a smartphone (Apple iOS or Android OS)
  • Baseline eating window ≥ 14 h/day
  • Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
  • Have been doing night shift work for at least 3 months.
  • Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are allowed
  • If patients have Type 2 Diabetes, they will be included in the study if A1c is less than 9 and they are not on insulin.

Exclusion Criteria:

  • Insufficient dietary logging on the mCC app is 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.
  • Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
  • Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
  • BMI > 50 kg/m2
  • Change in medications that could impact study outcomes within the past 3 months
  • Change in weight of >4kg in the past 3 months
  • Women who are pregnant, breastfeeding, or are trying to become pregnant during the study period. If a participant becomes pregnant during the study, they will be excluded from continuing the study.
  • 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
  • Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
  • Frequent (more than 4) travel involving a time zone change of more than 3 hours over the 1-year study period
  • Prolonged leave from work (a continuous month or longer) during the study
  • 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)
  • History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (hypothyroidism on a stable dose of thyroid replacement therapy is allowed).
  • 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
  • History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
  • Uncontrolled psychiatric disorder including prior hospitalization

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Dietary Monitoring

Log all dietary intake and continue habitual eating patterns.

experimental: Time-Restricted Eating (TRE)

Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window

experimental: Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS)

Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts.

Interventions

Dietary Monitoring

Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns.

Time-Restricted Eating (TRE)

Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window.

Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)

Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team.

Primary outcome measure

  • Total Body Fat Mass (kg) [ Time Frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up) ]

Central Contacts and Locations

Central contacts

UCSD Study Coordinator

858-246-2342research@mycircadianclock.org

Salk Clinical Researcher

858-453-4100research@mycircadianclock.org

Locations

University of California San Diego Altman Clinical and Translational Research Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

UCSD Study Coordinator

858-246-2342research@mycircadianclock.org

Salk Clinical Researcher

858-453-4100research@mycircadianclock.org

Principal Investigator:

Emily Manoogian, PhD

More Information

Sponsor

Salk Institute for Biological Studies

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Time-Restricted Eating
  • Night Shift work
  • Nurses
  • Nursing Assistants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salk Institute for Biological Studies on 2025-12-17.