Short-term fatigue Not Applicable
Conditions
Interventions
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 grou
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
Sponsors
ESSERRE Pharma S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Have been in fatigue for more than six months; 2. With an FSS questionnaire score> 5; 3. In conditions of pregnancy or breastfeeding; 4. Cognitive disorders that can hinder the response to questionnaires; 5. History of allergy to the ingredients contained in the treatments under study (dietary supplement and placebo); 6. Chronic pathologies or comorbidities from which the condition of fatigue could derive; 7. Malabsorption; 8. History of drug, drug or alcohol addiction or abuse; 9. Eating disorders; 10. Heart disease; 11. Chronic biliary and pancreatic liver diseases; 12. Neoplastic pathologies; 13. Genetic-metabolic diseases; 14. Diabetes; 15. Rheumatological diseases; 16. Chronic hematological diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed