2.1. Experimental Design
This was a double-blind, randomized, two-arm, within-subject crossover trial in which participants visited the laboratory on five occasions (one screening visit, two baseline visits, and two post-supplement testing visits). This study was conducted according to the guidelines laid down in the Declaration of Helsinki of 1975 and all procedures involving human subjects were approved by the Genetic Alliance IRB on 9/30/22 (#CSI-08-2022-001). Written informed consent was obtained from all subjects prior to enrollment. The study was registered on clinicaltrials.gov (“Effects of Dynamine Ingestion on Various Indices of Sustained Energy”, #NCT06048640). This study was conducted at a contract research organization (CRO) in Northeast Ohio. During the initial screening visit, each participant’s medical history and blood work (CBC, CMP, and lipid panel) were assessed, their baseline diet was evaluated, and each participant underwent 3 sets of familiarization trials of the neuropsychological assessments used within our testing procedures (Stroop and Trail Making Test B (TMT-B)). Since this study employed a crossover design, there were two baseline visits (one for each product tested). Thus, during the baseline visits (visits 2 and 4, which were prior to the supplementation administration), the subjects completed baseline testing which included subjective questionnaires (visual analog scales (VAS)) that assessed energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, and resilience to stress, in addition to completing 3 sets of neuropsychological assessments (Stroop and TMT-B) to assess their mental processing, cognitive flexibility, and attention. During visits 2 and 4, the participants completed the neuropsychological assessments twice with 10 min in between. At the conclusion of visits 2 and 4, the participants were given their respective supplements (i.e., placebo or Dynamine™) to take for three days and return on the fourth day. The participants returned for visits 3 and 5, where they took a fourth dose of their respective supplements at the laboratory and repeated the same testing procedures outlined at their baseline visits (visits 2 and 4), except they were administered at four timepoints (prior to ingestion of the 4th dose, 1 h, 2 h, and 3 h post-ingestion). There were no less than 7 days in between the completion of one investigational product and the start of the second investigational product (i.e., in between visits 3 and 4). For example, if a subject received the placebo first and Dynamine™ second, then visit 2 would be the baseline testing day for the placebo and visit 3 would coincide with the 4th consecutive dose for the placebo. The 4th dose of the placebo would be administered after the first round of testing (baseline/pre) on visit 3. There would then be at least 7 days before the participant would come back for a second baseline testing day (visit 4) for Dynamine™, and then come back a final time for the fourth consecutive dose of Dynamine™ (visit 5) to undergo the same testing procedures as in visit 3.