Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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