Quercetin Phytosome® Chronic Fatigue Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a 3-month period of quercetin supplementation (500 mg of Quercetin Phytosome®) is useful in the treatment of chronic fatigue, as assessed by the Fatigue Impact Scale (FIS-40). Secondary end points are sleep assessment through Pittsburgh Sleep Quality Index (PSQI) and muscle performance assessment through the Short Physical Performance Battery (SPPB) and body composition assessment using DXA.

Official Title
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Effectiveness of a 3-months Dietary Supplementation Based on Quercetin Phytosome®) for the Treatment of Chronic Fatigue Syndrome

Conditions
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Chronic Fatigue Syndrome, Sleep, Physical Performance, Body Composition

Intervention / Treatment
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* Dietary Supplement: Quercetin group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years old confirmed diagnosis of chronic fatigue syndrome according to the 1994 CDC / Fukuda definition Exclusion Criteria: patients with any active medical condition that explained chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, drug side effects and iron deficiency anemia), previous diagnosis not unequivocally resolved (chronic hepatitis, malignant tumors), past neuropsychiatric disorders o current (severe depressive disorder with psychotic or melancholy features, bipolar disorder, schizophrenia, delusional disorder, dementia, anorexia nervosa, bulimia nervosa) and participation in another clinical trial of the same or different nature within 30 days prior to inclusion in the study; failure to provide signed informed consent; consumption of certain drugs / supplements that could affect outcome measures in the past 90 days or whose discontinuation could be a significant problem, anticoagulant treatment, pregnancy or breastfeeding, smoking, alcohol or substance abuse, obesity (BMI> 30 kg / m2).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Dietary Supplement: Quercetin group<br>* 2 capsules a day of Quercetin Fitosoma® of 250 mg each<br>|
| Placebo Comparator: Placebo group<br> | Dietary Supplement: Placebo group<br>* 2 tablets per day, white film-coated having the same appearance as Quercetin Fitosoma ® tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic fatigue syndrome | The primary outcome is the change in self-reported fatigue scores assessed using the Fatigue Impact Scale (FIS-40) | At baseline and after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Sleep disturbances are assessed using the 19-item self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire. Scores are obtained on each of the seven sleep quality domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping pills, and daytime dysfunction. Each component is rated from 0 to 3 (0 = no sleep problems and 3 = severe sleep problems). The overall PSQI score ranges from 0 to 21 points, with scores ≥5 indicating worse sleep quality | At baseline and after 3 months | 
| Physical performance | Physical performance is assessed using the Short Physical Performance Battery test | At baseline and after 3 months | 
| Body composition | Body composition is assessed using the dual X-Ray absorptiometry (DXA) | At baseline and after 3 months | 
| Life quality | Quality of life is assessed using the Short-Form 12-Item Health Survey (SF-12), a short and generic measure of health status that reproduces the 2 summary scores of the SF-36, the summary of the physical component score and the summary score of the mental component, addressing eight health domains (physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health) | At baseline and after 3 months |