2.1. Study Design and Participants
The study was an adaptive randomized, double-blind, placebo-controlled trial with a parallel assignment, conducted in several North Carolina chiropractic clinics, including the Randolph Chiropractic Center (Charlotte, NC, USA), Trull Chiropractic (Kannapolis, NC, USA), Combined Chiropractic and Acupuncture (Charlotte, NC, USA), and the Nutrition Innovation Center (Kannapolis, NC, USA), from 2018 to 2022. The trial used an adaptive group sequential approach [A flow of the participants throughout the study is shown in At the beginning of the study, subjects were randomized to receive either a multi-component study intervention (study supplement and chiropractic care) or serve as controls (receive matched mineral oil placebo and chiropractic care) daily for 12 weeks. Randomization [All participants completed the study procedures and there were no protocol deviations. The investigators and outcome assessors were blinded to group allocation. The participant information and generated data were fully anonymized for data analysis and the interpretation of results. The study protocol and procedures were reviewed and approved by the Advarra Institutional Review Board (IRB), protocol no Pro00032192, and all clinical investigations were conducted according to the principles expressed in the Declaration of Helsinki. The study was registered on 