Summary

for people ages 21-65 (full criteria)
healthy people welcome
at La Jolla, California
study started
estimated completion:
Pam Taub

Description

Summary

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 Feeding in emergency responders who work a 24-hour shift schedule.

Official Title

Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters

Details

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 (TRF). 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 TRF 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 glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during the study.

Keywords

Shift Workers' Health First Responder Firefighters San Diego Fire and Rescue Cardiometabolic Health Shift Workers Time Restricted Feeding + Standard of Care Standard of Care

Eligibility

You can join if…

Open to people ages 21-65

  • Firefighter or work a 24-hr shift schedule with San Diego Fire and Rescue
  • Age: 21-65 years
  • Own a smartphone (Apple or Android Operating System)
  • If participants are on cardiovascular medications (HMG-CoA reductase inhibitors(statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period

You CAN'T join if...

  • Insulin-dependent diabetes mellitus
  • Presence of acute chronic inflammatory or autoimmune disease (defined by acute symptoms or C-reactive protein >10 mg/L), malabsorption syndromes, liver disease, or kidney disease (stage 3 or greater)
  • Uncontrolled thyroid disease
  • Intake of drugs likely to interfere with study endpoints, including corticosteroids,anabolic steroids, anti-psychotics, antiretroviral drugs, and immunosuppressive drugs(within 3 months of starting the study)
  • Presence or recent history of anemia (hematocrit <33% within 3 months of starting the study)
  • History of bariatric surgery
  • Pregnant or breast-feeding women
  • Current or recent (within 12 months of starting the study) pregnancy or breastfeeding,or intention of becoming pregnant in the next 6 months
  • Any cancer other than non-melanoma skin cancer in the last 3 years
  • On a special or prescribed diet for other reasons (e.g. Celiac disease)
  • Depression determined by the Beck Depression Inventory (BDI)
  • Planned international travel during study period
  • Insufficient logging on the mCC app (does not log at least 2 entries a day for 10 of 14 days) during baseline will exclude from being randomized into the intervention period

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03533023
Lead Scientist
Pam Taub
Study Type
Interventional
Last Updated
May 9, 2018