Quercetin Phytosome® Chronic Fatigue Syndrome

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730660
• Other study ID #: 0912/01072022
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Quercetin group
2 capsules a day of Quercetin Fitosoma® of 250 mg each
• Placebo group
2 tablets per day, white film-coated having the same appearance as Quercetin Fitosoma ® tablets.

Locations

Country	Name	City	State
Italy	l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Physical performance	Physical performance is assessed using the Short Physical Performance Battery test	At baseline and after 3 months
Secondary	Body composition	Body composition is assessed using the dual X-Ray absorptiometry (DXA)	At baseline and after 3 months
Secondary	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