Quercetin Phytosome® Chronic Fatigue Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Body Composition; Chronic Fatigue Syndrome; Physical Performance
• Intervention / Treatment: Dietary supplement: Quercetin group; Dietary supplement: Placebo group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: 0912/01072022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No