Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06891352

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers

Led by Salk Institute for Biological Studies · Updated on 2025-12-17

180

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

S

Salk Institute for Biological Studies

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Body mass index (BMI) of 25 kg/m2 or higher (23 kg/m2 or higher for Asian adults)
  • Own a smartphone with Apple iOS or Android operating system
  • Baseline eating window of 14 hours or more per day
  • Work as a nurse or nursing assistant on 12-hour night shifts at least 3 days per week
  • Have been working night shifts for at least 3 months
  • Patients on certain cardiovascular medications (statins, metformin, lipid-modifying drugs, anti-hypertensive drugs) are allowed
  • If diagnosed with Type 2 Diabetes, must have A1c less than 9 and not be on insulin
Not Eligible

You will not qualify if you...

  • Insufficient dietary logging on the myCircadianClock app during baseline (less than 7 of 14 days with minimum 2 items logged at least 5 hours apart)
  • Type 1 Diabetes or insulin-dependent Type 2 Diabetes
  • Use of sulfonylurea or insulin in the last 3 months
  • Use of weight loss medications such as SGLT2 inhibitors or GLP1 receptor agonists
  • Body mass index (BMI) greater than 50 kg/m2
  • Medication changes affecting study outcomes in the past 3 months
  • Weight change over 4 kg in the past 3 months
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Systolic blood pressure over 160 mmHg or diastolic over 110 mmHg at rest
  • Fasting LDL cholesterol over 250 mg/dL
  • Fasting triglycerides over 500 g/dL
  • Active tobacco or illicit drug use or history of alcohol abuse treatment in last 5 years
  • Frequent travel with time zone changes over 3 hours more than 4 times in a year
  • Prolonged leave from work of one month or longer during the study
  • Active treatment for inflammatory or rheumatologic diseases
  • Major cardiovascular event in the past year
  • Uncontrolled arrhythmia (rate-controlled atrial fibrillation/flutter allowed)
  • Recent thyroid dose changes in the past 3 months
  • Adrenal disease in past 5 years
  • Active cancer treatment in past 5 years except non-melanoma skin cancer
  • History of eating disorder in past 5 years
  • History of cirrhosis in past 5 years
  • Advanced kidney disease or dialysis in past 5 years
  • History of HIV/AIDS
  • Currently enrolled in a weight loss or management program
  • Weight loss surgery within past 2 years or longer if unsafe
  • Uncontrolled psychiatric disorder including prior hospitalization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California San Diego Altman Clinical and Translational Research Institute

La Jolla, California, United States, 92037

Actively Recruiting

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Research Team

U

UCSD Study Coordinator

CONTACT

S

Salk Clinical Researcher

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers | DecenTrialz