Quercetin Phytosome® Chronic Fatigue Symptoms

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Physical Performance; Chronic Fatigue Symptoms; Body Composition; Sleep

Treatments: Dietary Supplement: Quercetin group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT05730660

0912/01072022

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years old
• Chronic fatigue symptoms recorded using a self-reported fatigue score assessed using the validated Fatigue Impact Scale (FIS- 40) that comprised chronic tiredness impacts related to physical, cognitive and psychosocial functions.

Exclusion criteria

• Patients with any active medical condition that explains 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 or current severe depressive disorder with psychotic or melancholy features, bipolar disorder, schizophrenia, delusional disorder, dementia, anorexia nervosa, bulimia nervosa
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Treatment:

Dietary Supplement: Quercetin group

Placebo group

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo group