Optimizing meal timing to improve health in night shift workers
Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study
This study tests if changing when night shift workers eat can help them lose weight and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Salk Institute for Biological Studies Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06891352 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the health effects of optimizing dietary timing in nurses and nursing assistants who work night shifts and have elevated weight. Participants will be randomly assigned to one of three groups: dietary monitoring, dietary monitoring with a 10-hour daytime eating window, or time-restricted eating with a low-glycemic snack during night shifts. The study aims to determine if these dietary adjustments can reduce weight, improve glucose regulation, and enhance other metabolic and cardiovascular health markers over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are night shift nurses and nursing assistants aged 18-70 with a BMI of 25 or higher and a habitual eating window of 14 hours or more.
Not a fit: Patients with Type 1 Diabetes or those who are insulin-dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health and well-being of night shift workers by reducing obesity and related health risks.
How similar studies have performed: Previous studies on time-restricted eating have shown promising results in improving metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California
- University of California San Diego Altman Clinical and Translational Research Institute — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Emily Manoogian, Ph.D. — Salk Institute for Biological Studies
- Study coordinator: UCSD Study Coordinator
- Email: research@mycircadianclock.org
- Phone: 858-246-2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.