Singh, Ruma G.
Garcia-Campayo, Vicenta
Green, Justin B.
Paton, Neil
Saunders, Julissa D.
Al-Wahsh, Huda
Crowley, David C.
Lewis, Erin D.
Evans, Malkanthi
Moulin, Marc
Article History
Received: 20 December 2023
Revised: 10 May 2024
Accepted: 27 May 2024
First Online: 28 June 2024
Competing interests
: V.G.C, J.G, N.P, J.D.S. are employees of Cargill Limited c/o Cargill Inc., R.S, M.M, D.C.C, H.A, E.D.L are employees of KGK Science Inc., M.E is a faculty member at Western University. All authors declare no competing interests.
: This randomized, double-blind, placebo-controlled, parallel study was conducted at KGK Science Inc. (London, Ontario, Canada) from September 2022 to April 2023. The study was reviewed by the Natural and Non-Prescription Health Products Directorate (NNHPD), Health Canada, Ottawa, Ontario and approved on March 03, 2022. Ethics approval was granted on June 17, 2022, by the Institutional Review Board Services (Aurora, Ontario, Canada; Pro00063328). The trial followed CONSORT guidelines for randomized controlled trials<sup>20</sup> (Supplementary Table ) and written informed consent was obtained from all participants prior to the initiation of any study procedures. The study was registered with Clinicaltrials.gov (NCT05492370).
: Each participant and their parent(s) or legal guardian gave written informed consent to participate in the study.