2.3. Clinical Trial Design
fatigue
A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed by COMEGEN—Società Cooperativa Sociale (Naples, Italy) to evaluate the efficacy of the food supplement based on pomegranate extract and vitamins C and B complex in adults with mild to moderate prolonged fatigue. The study was double-blind, both for the investigating physician and for the enrolled subjects. For this purpose, both the food supplement and the placebo were made to be unrecognizable in shape, weight, color, and, as far as possible, taste. The participants received verbal and written information regarding the study before signing a written consent. Protocol, letter of intent of volunteers, and synoptic documents regarding the study were approved by the Scientific Ethics Committee of A.S.L. Napoli 1 CENTRO (deliberation No. 1953—11 November 2022) and carried out in accordance with the Helsinki Declaration of 1964 (as revised in 2000). This study is listed on the ISRCTN registry (The study design was composed of two experimental groups (Thus, the total duration of the study was about five months following the enrollment of the subjects and included two months of treatment.