Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSalk Institute for Biological Studies
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Dietary Monitoring
- Time-Restricted Eating (TRE)
- Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Salk Institute for Biological Studies
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of San Diego
Collaborator
Source ClinicalTrials.gov