Quercetin Phytosome® Chronic Fatigue Symptoms

NCT ID: NCT05730660

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Fatigue Symptoms Sleep Physical Performance Body Composition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Group Type EXPERIMENTAL

Quercetin group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quercetin group

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

Intervention Type DIETARY_SUPPLEMENT

Placebo group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Pavia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0912/01072022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Creatine Supplementation in Chronic Fatigue Syndrome
NCT02374112 ACTIVE_NOT_RECRUITING NA