The study of the effect of Guayusa herbal extract on alertness and mental fatigue

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PepsiCo Global R&D is recruiting patients for the clinical trial of Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue.

The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by ~7 days.

The researchers plan that July 27, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in November 30, 2022.

Among primary outcome measures are the Mental alertness and Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Increased alertness is better.

The study will take place at the Biofortis Innovation Services, Division of Merieux NutriSciences, Addison, Illinois, United States.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05530915.

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