Quercetin Phytosome® Chronic Fatigue Symptoms

NCT05730660 | Completed

• 1 other identifier: 0912/01072022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Symptoms; Sleep; Physical Performance; Body Composition

Outcome Measures

Primary Outcomes (1)

• chronic fatigue symptoms

  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.

  At baseline and after 3 months

Secondary Outcomes (4)

• Sleep quality

  At baseline and after 3 months

• Physical performance

  At baseline and after 3 months

• Body composition

  At baseline and after 3 months

• Life quality

  At baseline and after 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Dietary Supplement: Quercetin group

Placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo group

Interventions

Quercetin group DIETARY_SUPPLEMENT

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

Intervention group

Placebo group DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

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

Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: August 6, 2024

Record last verified: 2023-02

Locations

IT (1)