2.2. Food Supplement Based on Pomegranate Extract and Hydro-Soluble Vitamins
Food supplements based on pomegranate extract, hydro-soluble vitamins (vitamins C and B complex), and placebo were produced by Esserre Pharma Srl (Rome, Italy) within European specifications for contaminants and microbiologic limits and notified to the Italian Health Ministry with the brand name Improve™ (notification number: I.5.i.h.2/2021/139191). The food supplement was produced in the form of soluble granulesin single-dose stick packs (1.6 g) containing 500 mg of pomegranate extract, 200 mg of vitamin C (L-ascorbic acid), 16 mg of niacin (nicotinamide), 7 mg of vitamin B2 (riboflavin), 6 mg of vitamin B5 (D-pantothenate, calcium), 5.55 mg of vitamin B1 (thiamine hydrochloride), 4 mg of vitamin B6 (pyridoxine hydrochloride), 200 µg of folate (pteroylmonoglutamic acid), 50 µg of D-biotin and 12.5 µg of vitamin B12 (cyanocobalamin). Placebo, in the same form of soluble granules, consisted of inert excipients (i.e., pomegranate flavor, beetroot red, maltodextrin, stevia, silicon dioxide, beta-carotene, caramelized sugar, citric acid, and xanthan gum), and considering the protocols of the double-blind study, it was made indistinguishable in color and flavor from the food supplement.