2.4. Participants and Recruiting
fatigue, inflammation, chronic hematological disorders, allergy, substance abuse, malabsorption or eating disorders, chronic diseases or co-morbidities, rheumatological ailments, cognitive impairments, chronic hepatic, biliary and pancreatic diseases
INFLAMMATION, ALLERGY, DIABETES TYPE 1, HEART DISORDERS, DISEASES
Fifty-eight subjects aged 18–75 years of either sex were recruited by general practitioners through Comegen in February 2023 and randomized into two groups. Inclusion criteria for the study were defined as subjects with mild-to-moderate fatigue, with an FSS questionnaire score of less than 5, that were able to understand and sign the informed consent. Subjects with chronic fatigue (i.e., ˃six months) or an FSS score ≥ 5, pregnant or lactating women, subjects with cognitive impairments (that may hinder response to the questionnaires), subjects with a history of allergy to the ingredients used in the clinical trial (food supplement and placebo), subjects with chronic diseases or co-morbidities that may cause or aggravate fatigue symptoms (i.e., heart disorders, chronic hepatic, biliary and pancreatic diseases, neoplastic pathologies, rheumatological ailments, chronic hematological disorders, neuropsychiatric or neurological conditions, genetic-metabolic diseases, and diabetes type 1 or 2), candidates with malabsorption or eating disorders, subjects with a history of substance abuse or misuse (including drugs or alcohol), and subjects using multivitamin supplements within the previous month were excluded from the study. Additionally, subjects who used prescription or over-the-counter drugs that may have influenced cerebral excitability (i.e., tricyclic antidepressants, hypnotic drugs, anti-epileptics, antipsychotics, stimulants, antihistamines, muscle relaxants, dopaminergic drugs, and sedative-hypnotics) or drugs affecting systemic inflammation and levels of inflammatory mediators (i.e., non-steroidal and steroidal anti-inflammatory drugs) in the week prior to enrollment were rigorously evaluated for possible exclusion from the clinical study by the investigating clinician.