The beneficial effect on short-term fatigue of a food supplement based on pomegranate, vitamin C and vitamins of group B.

INTERVENTION: The subjects recruited in the present clinical study will consume a food supplement based on a pomegranate extract, vitamin C and B vitamins, or a placebo, for 56 days, based on the randomization group. Following the above‐cited treatment period, participants will undergo a follow‐up period of 28 days, in which participants do not receive any treatments. The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list will be kept hidden. The participants will be assigned to each of the two treatment groups (food supplement or placebo) casually and by simple randomization (1:1 allocation ratio). The randomization code will consist of a three‐digit number as indicated in the respective Case Report Form (CRF). In the clinical study, 58 participants will be enrolled and divided into two groups (29 for each group): ‐ Group 1: food supplement containing pomegranate extract, vitamin C, and B vitamins. ‐ Group 2: placebo. Participants will undergo to four visits (baseline = t0; after 28 days of treatment = t1; after 56 days of treatment = t2; after 28 days from the end of treatment = t3) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. The clinical trial design is reported below: During the screening visit, subjects will undergo the following investigation to understand if they meet the study participation requirements: ‐ Administration of the FSS questionnaire. Subsequently, all enrolled subjects will undergo the following: CONDITION: Short‐term fatigue ; Not Applicable PRIMARY OUTCOME: ; Fatigue measured by the Fatigue Severity Scale (FSS). Nine‐item self‐assessment questionnaire that assesses both physical and mental symptoms of fatigue. The subject is invited to read the sentences carefully and, for each of them, must choose a number from 1 to 7 (1 indicates absolute disagreement with the statement, while 7 indicates complete agreement). The answers to the questions must refer to the last two weeks.; TIME FRAME of the assessment: at baseline (t0), 28 days (t1), 56 days (t2) of treatment, and after 28 days from the end of treatment (t3).; INCLUSION CRITERIA: 1. Healthy subjects, according to what was determined by the clinical history and by the information provided during the recruitment; 2. Aged between 18 and 75 years; 3. Who has been in a condition of medium or moderate fatigue and fatigue for at least one month; 4. With FSS score < 5; 5. Able to understand and sign the informed consent. SECONDARY OUTCOME: ; 1. Measurement of biomarkers related to fatigue and stress conditions. The following biomarkers will be analyzed in blood samples:; 1.1. C‐reactive protein (CRP); 1.2. Cortisol; 1.3. Pro‐inflammatory interleukin: IL‐6; In addition, the following biochemical parameters will be analyzed in order to evaluate the effect of dietary supplementation with the food supplement:; 1.4 Magnesium, Potassium, Calcium,; 1.5. Creatine phosphokinase,; 1.6. Vitamins of group B,; 1.7. Vitamin D.; TIME FRAME of the assessment: at baseline (t0), and at 56 days (t2) of treatment.; 2. Measurement of perceived quality of life with the “Short Form Health Survey‐12” (SF‐12) questionnaire.; TIME FRAME of the assessment: at baseline (t0), 28 days (t1), 56 days (t2) of treatment, and after 28 days from the end of treatment (t3).;