An interventional study of Time Restricted Eating + Standard of Care and Standard of Care in Shift Workers' Health, Time Restricted Eating and Fasting, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
This is the first study of its kind to assess and test an intervention to improve biological rhythms and general health of shift workers, specifically first responders with San Diego Fire and Rescue. In a randomized control trial, investigators intend to measure the health impact of Time Restricted Eating in emergency responders who work a 24-hour shift schedule.
Participants will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of standard of care with the addition of adopting a 10 hour eating window for one year (TRE). For the first 3 months of intervention, participants will be monitored closely by the research team. For the following 9 months, participants will be in a self-monitored intervention period. Investigators will evaluate the impact of TRE on blood glucose levels, biomarkers, sleep/mood, and weight loss. These assessments will be made at baseline, at the end of the 12-week monitored intervention period, and every 3 months (months 6, 9, and 12) during the self-monitored intervention period for one year. Food/drink intake, activity, and sleep will be monitored with the smartphone myCircadianClock application ("mCC app") throughout the study. A continuous glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during the study.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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As per recommendations from the fire department, fire department unions, and funding agencies, we did not require compromised health measures (e.g. hyperglycemia, hypertension, etc.) as inclusion criteria for they would be discriminatory against some firefighters.
Inclusion Criteria:
Exclusion Criteria:
Time Restricted Eating + Standard of Care
Behavioral: Time Restricted Eating + Standard of Care
Standard of Care
Behavioral: Standard of Care
Participants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietician.
Also known as: Time Restricted Eating
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
Evaluate the impact of TRE on glucose homeostasis at end of intervention compared to baseline
Measured by an ambulatory continuous glucose monitoring device and blood work throughout the study. Note: Significant changes expected in participants who had elevated glucose homeostasis at baseline. No significant changes expected in those within normal ranges at baseline. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Assess the feasibility and adherence of TRE
Measured by percentage of days logged that participants ate within their 10-hour window and by end of study responses. Note: Significant changes expected in participants in the TRE arm of the study on and off shift. No significant changes expected in the standard of care arm of the study. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Assess changes in metabolic biomarkers in response to TRE at end of intervention compared to baseline
Measured with blood biochemistry.Measured with blood biochemistry under TRE, including, but not limited to: fasting glucose, HbA1c, cholesterol, and triglycerides. Note: Significant changes expected in participants who had abnormal levels at baseline (e.g. elevated LDL cholesterol, low HDL cholesterol, elevated triglycerides). No significant changes expected in those were within normal ranges at baseline.
Time frame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Systolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Measured at baseline and during TRE intervention. Note: Significant changes expected in participants who had elevated systolic blood pressure at baseline. No significant changes expected in those without elevated systolic blood pressure at baseline.
Time frame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Diastolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Measured at baseline and during TRE intervention. Note: Significant changes expected in participants who had elevated diastolic blood pressure at baseline. No significant changes expected in those without elevated diastolic blood pressure at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Body weight (kg)
Measured on a digital scale. Note: Significant changes expected in participants who had elevated weight at baseline. No significant changes expected in those who were not overweight at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m). Note: Significant changes expected in participants who had elevated BMI at baseline. No significant changes expected in those whose BMI was not elevated at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Waist and hip circumference (cm)
Measured with standardized body tape measure. Note: Significant changes expected in participants who had increased waist and hip circumference at baseline. No significant changes expected in those without increased waist and hip circumference at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Hip (cm)/waist (cm) ratio
Measured using tape measure. Note: Significant changes expected in participants who had an increased hip/waist ratio at baseline. No significant changes expected in those without increases at baseline
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Body composition including but not limited to fat percentage (%), fat mass (kg), and lean mass (kg)
Measured by Tanita Digital Scale. Note: Significant changes expected in participants who had elevations levels at baseline. No significant changes expected in those without elevations at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Questionnaires (quality of life, sleep, and health)
Measured by SF-36, PSQI, and ESS. Note: Significant changes expected in participants who had decreased self-reporting of the above-mentioned questionnaires at baseline. No significant changes expected in those without decreases at baseline.
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of California, San Diego