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Completed

NCT Number: NCT05730660

Quercetin Phytosome® Chronic Fatigue Symptoms

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.

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Key information

Conditions

Chronic Fatigue Symptoms Body Composition Physical Performance Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quercetin group

Dietary Supplement

2 capsules a day of Quercetin Fitosoma® of 250 mg each

Placebo Group

Dietary Supplement

2 tablets per day, white film-coated having the same appearance as Quercetin Fitosoma ® tablets.

Primary outcomes

  1. chronic fatigue symptoms

    Time frame: At baseline and after 3 months

    The primary outcome is the change in self-reported fatigue scores assessed using the Fatigue Impact Scale (FIS-40). The FIS-40 comprises 40 items divided into three domains (cognitive, physical, and psychosocial), each item scored from 0 (no fatigue) to 4 (severe fatigue). The total score ranges from 0 to 160, with higher scores indicating worse fatigue.

Secondary outcomes

  1. Sleep quality

    Time frame: At baseline and after 3 months

    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

  2. Physical performance

    Time frame: At baseline and after 3 months

    Physical performance is assessed using the Short Physical Performance Battery test

  3. Body composition

    Time frame: At baseline and after 3 months

    Body composition is assessed using the dual X-Ray absorptiometry (DXA)

  4. Life quality

    Time frame: At baseline and after 3 months

    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). Each domain is scored separately, and the total scores for the physical and mental components range from 0 to 100, with higher scores indicating better health-related quality of life.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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