Back to resultsQuercetin Phytosome® Chronic Fatigue Syndrome
Primary Purpose
Chronic Fatigue Syndrome, Sleep, Physical Performance
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Quercetin group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
Eligibility Criteria
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).
Sites / Locations
- l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
chronic fatigue syndrome
The primary outcome is the change in self-reported fatigue scores assessed using the Fatigue Impact Scale (FIS-40)
Secondary Outcome Measures
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
Physical performance
Physical performance is assessed using the Short Physical Performance Battery test
Body composition
Body composition is assessed using the dual X-Ray absorptiometry (DXA)
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)
Full Information
NCT ID
NCT05730660
First Posted
February 7, 2023
Last Updated
February 7, 2023
Sponsor
Azienda di Servizi alla Persona di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05730660
Brief Title
Quercetin Phytosome® Chronic Fatigue Syndrome
Official Title
Effectiveness of a 3-months Dietary Supplementation Based on Quercetin Phytosome®) for the Treatment of Chronic Fatigue Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Sleep, Physical Performance, Body Composition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin group
Intervention Description
2 capsules a day of Quercetin Fitosoma® of 250 mg each
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
2 tablets per day, white film-coated having the same appearance as Quercetin Fitosoma ® tablets.
Primary Outcome Measure Information:
Title
chronic fatigue syndrome
Description
The primary outcome is the change in self-reported fatigue scores assessed using the Fatigue Impact Scale (FIS-40)
Time Frame
At baseline and after 3 months
Secondary Outcome Measure Information:
Title
Sleep quality
Description
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
Time Frame
At baseline and after 3 months
Title
Physical performance
Description
Physical performance is assessed using the Short Physical Performance Battery test
Time Frame
At baseline and after 3 months
Title
Body composition
Description
Body composition is assessed using the dual X-Ray absorptiometry (DXA)
Time Frame
At baseline and after 3 months
Title
Life quality
Description
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)
Time Frame
At baseline and after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Quercetin Phytosome® Chronic Fatigue Syndrome
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