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Article History

Received: 21 October 2025

Accepted: 4 February 2026

First Online: 26 March 2026

Declarations

:

: This study was sponsored by DSM Nutritional Products AG (now dsm-firmenich Switzerland AG), who developed CBtru ® . Igor Bendik, Mareike Beck, Franz Roos, Deanna McCarthy, Christiane Schweiggert, Ahmed Besheer, Zdravka Misic, Bernd Mussler and Szabolcs Peter are employees of dsm-firmenich Switzerland AG. Anu Manderna, Jun Wang, Josh Baisley, and Adam Kuttenkeuler are employed by Nutrasource Pharmaceutical and Nutraceutical Services, the company that dsm-firmenich Switzerland AG contracted to conduct the study.

: This trial was conducted in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and ethical principles that have their origin in the Declaration of Helsinki. Protocols were approved by the Advarra Institutional Review Board (6100 Merriweather Dr., Suite 600, Columbia, Maryland 21044) before eligibility screening.

: All participants signed an informed consent form as evidence of consent.

: Not applicable.

: The datasets generated and/or analyzed during the current trial are not yet publicly available.

: The code used for data analysis in this study is not yet publicly available.

: All authors contributed to the creation and design of the trial. Igor Bendik and Szabolcs Peter developed the final trial concept. Adam Kuttenkeuler managed the execution of the trial at Nutrasource. At dsm-firmenich, Igor Bendik served as the study director, while Zdravka Misic and Deanna McCarthy acted as project managers. Zdravka Misic, Christiane Schweiggert and Ahmed Besheer managed production of the CBtru ® study material. Franz Roos, Mareike Beck and Jun Wang were responsible for the statistical planning outlined in the protocol and the statistical analysis plan. Josh Baisley, Mareike Beck, Igor Bendik, Szabolcs Peter and Anu Manderna interpreted the study results. The first version of the manuscript was drafted by Anu Manderna, and all authors (Szabolcs Peter, Igor Bendik, Mareike Beck, Deanna McCarthy, Zdravka Misic, Franz Roos, Jun Wang, Christiane Schweiggert, Ahmed Besheer, Josh Baisley, Bernd Mussler, Daniele Piomelli, Adam Kuttenkeuler) critically contributed to the subsequent drafts. All named authors meet the authorship criteria of the International Committee of Medical Journal Editors (ICMJE), accept full responsibility for the integrity of the work as a whole, and have approved the final version for publication.