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

Launched by SALK INSTITUTE FOR BIOLOGICAL STUDIES · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the timing of meals can affect the health of nurses and nursing assistants who work night shifts and may be overweight. Researchers want to find out if changing when they eat—like having a shorter eating window during the day—can help improve their health. Participants will be divided into three groups: one will only track their eating habits, another will track their eating and have a 10-hour eating window during the day, and the last group will follow the same eating window but have a low-sugar snack at night. The study will last for 12 months, with health check-ups at different points along the way.

To join the study, participants need to be between 18 and 70 years old, have a body mass index (BMI) of 25 or higher, and currently work at least three night shifts a week. They also need to have a smartphone to log their meals. People with certain medical conditions or those taking specific medications may be excluded, so it’s important to check the full eligibility criteria. If you decide to participate, you will receive support and monitoring throughout the study to help track any changes in your health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18-70 years
• • BMI ≥ 25 kg/m2
• • 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 \> 42 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
• • Any history of surgical intervention for weight management
• • Uncontrolled psychiatric disorder including prior hospitalization