Effectiveness of a 3-months Dietary Supplementation Based on Quercetin Phytosome®) for the Treatment of Chronic Fatigue Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- chronic fatigue symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
chronic fatigue symptoms
时间窗: 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.
次要结局
- Sleep quality(At baseline and after 3 months)
- Body composition(At baseline and after 3 months)
- Physical performance(At baseline and after 3 months)
- Life quality(At baseline and after 3 months)