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NCT06891352Recruiting

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

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study

Source: ClinicalTrials.gov · Last updated 17 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
12 Mar 2025
Start date
2 Jun 2025
Primary completion date
31 Aug 2028
Lead sponsor
Salk Institute for Biological Studies
Diseases
Obesity
NCT number
NCT06891352

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 2 Jun 2025 to the primary completion date, 31 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
  • Change in medications that could impact study outcomes within the past 3 months
  • Uncontrolled psychiatric disorder including prior hospitalization

Other illness

  • Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
  • Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
  • 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
  • History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators

Lab values

  • Fasting LDL cholesterol greater than 250 mg/dL

Other

  • 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.
  • Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
  • BMI \> 50 kg/m2
  • 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 triglycerides greater than 500g/dL
  • 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
  • Currently enrolled in weight-loss or weight-management program

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California, San Diego Altman Clinical and Translational Research Institute
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.