Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06891352

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

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

180

Participants Needed

1

Research Sites

26 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

Researchers are studying nurses and nursing assistants who work night shifts, have elevated weight, and a habitual eating window of 14 hours or more. The study aims to evaluate whether reducing daily eating hours and consolidating food intake to daytime, with or without a low-glycemic snack during night shifts, can improve weight, abdominal fat, glucose regulation, and other metabolic and cardiovascular health markers. This research focuses on the effects of time-restricted eating (TRE) on the health of night shift workers, a group not yet studied in this context. Participants will be randomly assigned to one of three groups: dietary monitoring alone, dietary monitoring with a personalized consistent 10-hour TRE window, or TRE with a low-glycemic snack provided during night shifts. The TRE group consumes only water, black coffee, and tea without additives during night shifts. The study lasts one year and includes a 2-week screening and baseline period, a 6-month guided intervention, and a 6-month self-guided intervention. Throughout the study, participants will log dietary intake on a smartphone app and wear devices to monitor glucose levels, activity, sleep, and wrist temperature. Health assessments will occur at baseline, 3, 6 (primary outcome), and 12 months, measuring body fat, weight, blood pressure, blood markers, body composition scans, and questionnaires on sleep and quality of life. Researchers will track adherence and metabolic health changes to understand how altering eating patterns impacts night shift workers' health.

CONDITIONS

Brief 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, or 23 kg/m2 or higher for Asian adults
  • Own a smartphone with Apple iOS or Android OS
  • Baseline eating window of 14 hours or more per day
  • Night shift nurses and nursing assistants working at least three 12-hour night shifts per week
  • Night shift work experience of at least 3 months
  • Use of certain cardiovascular medications is allowed
  • If diagnosed with Type 2 Diabetes, A1c must be less than 9 and not using insulin
Not Eligible

You will not qualify if you...

  • Insufficient dietary logging on the myCircadianClock app during baseline
  • Diagnosis of 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 over 50 kg/m2
  • Changes in medications or weight greater than 4 kg in the past 3 months
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study
  • High blood pressure above specified limits at rest
  • Very high fasting LDL cholesterol or triglycerides
  • Active tobacco, illicit drug use, or recent history of alcohol abuse treatment
  • Frequent travel across time zones exceeding specified limits
  • Prolonged work leave of one month or more during the study
  • Active inflammatory or rheumatologic disease treatment
  • Major cardiovascular events within the past year
  • Uncontrolled arrhythmias except certain stable conditions
  • Recent thyroid medication changes
  • History of adrenal disease, malignancy, eating disorder, cirrhosis, severe kidney disease, HIV/AIDS
  • Current enrollment in weight-loss programs or recent surgical weight management
  • Uncontrolled psychiatric disorders including prior hospitalization

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Guided Intervention

Duration - 6 months

Participants follow their assigned dietary plan, which includes dietary monitoring alone or with a personalized 10-hour time-restricted eating window, with or without a low-glycemic snack during night shifts.

Visits at baseline, 3 months, and 6 months for health assessments

Self-Guided Intervention

Duration - 6 months

Participants continue their assigned dietary plan on their own without guided support.

Visit at 12 months for follow-up health assessments

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

S

Salk Clinical Researcher

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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