The Healthy Heroes Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03533023|
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Shift Workers' Health Time Restricted Eating Fasting||Behavioral: Time Restricted Eating + Standard of Care Behavioral: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study|
|Actual Study Start Date :||May 8, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: TRE + SOC
Time Restricted Eating + Standard of Care
Behavioral: Time Restricted Eating + 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.
Other Name: Time Restricted Eating
Standard of Care
Behavioral: Standard of Care
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 TRF on glucose homeostasis [ Time Frame: 1 year ]Measured by an ambulatory continuous glucose monitoring device and blood work throughout the study.
- Assess changes in metabolic biomarkers in response to imposed feeding/fasting cycles [ Time Frame: 1 year ]Measured with blood biochemistry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533023
|Contact: Hannah Lo, BSfirstname.lastname@example.org|
|Contact: Adena Zadourian, BSemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Hannah Lo, BS 858-246-2510 firstname.lastname@example.org|
|Contact: Adena Zadourian, BS 858-246-2510 email@example.com|
|Principal Investigator: Pam Taub, MD|
|Principal Investigator:||Pam Taub, MD||UCSD|