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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dietary Monitoring
BehavioralParticipants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns.
Time-Restricted Eating (TRE)
BehavioralParticipants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window.
Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)
BehavioralParticipants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Dietary MonitoringActive comparator 1 intervention
Group B: Time-Restricted Eating (TRE)Experimental treatment 1 intervention
Group C: Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total Body Fat Mass (kg)
Total Body Fat Mass (kg) assessed by DXA
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)Secondary outcomes
1
Body weight (kg) in clinic
Body weight (kg) measured in clinic while participants are wearing a gown that has been weighed.
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)2
Body Mass Index
Body Mass Index (BMI) (kg/m2)
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)3
HbA1c (%)
Hemoglobin A1c (%) from fasted blood draw
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)4
Intra-Daily Glycemic Variability: CONGA (A.U.)
Continuous Overall Net Glycemic Action (CONGA) assessed via continuous glucose monitor
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)Other outcomes
1
Lean Mass (g)
Whole body lean mass (g) assessed by DXA scan
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)2
Percent Body Fat (%)
Whole body percent Body Fat (%) assessed by DXA scan
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)3
Visceral Adipose Tissue Mass (g)
Whole body Visceral Adipose Tissue Mass (g) assessed by DXA scan
Time frame
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)4
Body Weight (kg) at home
Participants will weigh themselves every 2 weeks at home on study provided scales in the morning.
Time frame
From enrollment to the end of the intervention at 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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