Participants
hepatic and renal disease, hypersensitivity, eating disorders, hepatic and renal diseases
DISEASES, HYPERSENSITIVITY, BLEEDING DISORDERS, NEUROLOGICAL DISORDERS
This randomized, placebo-controlled, double-blind pilot study was conducted according to the Declaration of Helsinki for Research on Human Subjects guidelines and approved by the Human Ethics Committee of the University of Milano-Bicocca (Milano, Italy). The study was also registered on ClincalTrials.gov, NCT04965948.The study was conducted at Complife Italia s.r.l. (Milano, Italy) from June 2019 to March 2021.One-hundred and thirty-five Caucasian subjects were considered eligible for the study, according to the following inclusion criteria i) aged ≥65 years; ii) free-living; iii) not on long-term regular vitamin/EPA or DHA supplementation; iv) not affected by hepatic and renal diseases, bleeding disorders; mental and neurological disorders; severe eating disorders; and exclusion criteria were i) known or suspected hypersensitivity to one or more ingredients of the snack; ii) institutionalized; iii) presence of certain diseases, including hepatic and renal disease, bleeding disorders; mental and neurological disorders, severe eating disorders; iv) subjects on long-term regular vitamin/EPA or DHA supplementation.Out of 135 eligible subjects, 66 volunteers (21 male, 45 female) aged 64–80 years (70,6 ± 4,5 years of age) gave their consent to participate in the pilot study. At last, due to the inability to attend the follow-up, and Covid-19 restrictions, only 50 participants completed the protocol.