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Article History

Received: 10 July 2024

Accepted: 6 December 2024

First Online: 21 December 2024

Declarations

:

: The trial received approval from the UF IRB approval on 30/06/2023 with the IRB number IRB202300887. It is registered in the Clinical Trials Registry under the identifier: NCT05814055 . Prior to enrollment, study coordinators will secure consent from all participants. The informed consent form contains details about data and biological specimen collection, as well as procedures for transcribing interview recordings, in addition to study information.

: Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant’s PI, holds a 55% ownership stake in KH. Additionally, he offers advises KH regarding its strategic direction and development. As of now, KH has not generated any product or profit from his KH stock. He offers KH with development consultations.

: Thorne used the intellectual properties (IPs) owned by Kuality Herbceutics (KH) to develop the AB-free kava product under investigation. Chengguo Xing, the grant’s PI, holds a 55% ownership stake in KH. Additionally, he offers advises KH regarding its strategic direction and development. As of now, KH has not generated any product or profit from his KH stock. He offers KH with development consultations.

: The study staff are extensively trained in research procedures aimed at safeguarding participants’ privacy and are accustomed to upholding confidentiality in all their activities. Additionally, all team members will complete a human subject training course before the study commences. Any reported or suspected privacy concerns will promptly be communicated to the PI.Multiple measures are implemented to protect the identities of participants. Data files will be coded, and numerical identification codes will be assigned to participants to prevent any potential identification. Informed consent documents will be kept in locked filing cabinets behind closed doors, accessible only to authorized study personnel. Information that includes identifiers will be maintained at a separate site from the study data. Furthermore, the data storage facility will have restricted, key-controlled access, adding an extra layer of security. Data collected during the study will be entered into the HIPAA-compliant REDCap application.

: No significant adverse events are anticipated from this study; therefore, participants who may experience harm during the trial will not receive compensation.

: All findings will be documented in ClinicalTrials.gov. The results of the trial will be distributed through academic journals that are both open-access and peer-reviewed to ensure broad accessibility will be published in open-access scholarly journals to ensure broad accessibility. The full protocol, complete statistical code and participant-level dataset can be granted via the corresponding author. Additionally, the results will be shared with the public through poster and conference presentations.

: 0002.0

: National Institute of Health: National Center for Complementary and Integrative Health. Recruitment is anticipated to conclude on 06/2026.