Cohen-Mekelburg, Shirley
Goldstein, Cathy A.
Rizvydeen, Muneer
Fayyaz, Zainab
Patel, Priya J.
Berinstein, Jeffrey A.
Bishu, Shrinivas
Cushing-Damm, Kelly C.
Kim, Hyungjin Myra
Burgess, Helen J.
Funding for this research was provided by:
Foundation for the National Institutes of Health (R01 DK136520, K23DK134764, K08DK123403, K08DK133640)
Article History
Received: 17 April 2024
Accepted: 14 May 2024
First Online: 22 May 2024
Declarations
:
: The study protocol follows the Standard Protocol Items: Recommendations for interventional trials (SPIRIT) 2013 and has been approved by the institutional review board (IRB) of the University of Michigan Medical School (IRB# HUM00234262). The study started recruitment in February 2024, and the study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024. All human subjects will be required to sign an informed consent document prior to study participation.
: Not applicable.
: HJB is a consultant for Natrol, LLC. All other authors report no financial or non-financial interests to disclose.