Study on the Efficacy of Quercetin Intake in Patients With Idiopathic Pulmonary Fibrosis and Non-Idiopathic Pulmonary Fibrosis. A Two-arm, Prospective Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Blood Leukocyte Telomere length
研究概览
简要总结
Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved antifibrotic treatment. While its exact cause remains unknown, pulmonary fibrosis is strongly linked to aging, genetic predisposition, environmental factors, and cellular senescence. Ongoing research aims to identify reliable biomarkers and develop targeted treatments to enhance patient outcomes.
This randomized controlled trial will examine the effects of quercetin supplementation (500 mg/day for two 12-week cycles, with one 8-week washout periods) on telomere length, senescence-associated secretory phenotype (SASP) factors, and lung function in patients with IPF and F-ILDs. A total of 100 patients will be recruited, with half receiving quercetin (despite their standard of care therapy) and the other half receiving standard care (SOC). Primary outcomes will include changes in telomere length, SASP protein levels (IL-6, MMPs), fractional exhaled nitric oxide (FeNO), spirometry (FVC decline), and oscillometry measurements. Additionally, quality of life will be assessed using the L-IPF Questionnaire.
This study aims to explore quercetin's potential to reduce fibrosis, decrease inflammation, and improve lung function in F-ILDs, offering new insights into potential novel strategies for F-ILD management.
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
- None
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
- •Patients with an established diagnosis of IPF and Fibrotic ILD and will be eligible to participate in the study.
- •The use of the approved standard of care antifibrotic therapy, either nintedanib or pirfenidone, and immunosuppressive therapy will be allowed as standard of care.
排除标准
- •Subjects with a result of FeNO>25 ppb will be excluded from the study to ensure that no other pulmonary diseases, such as asthma, are present.
- •Patients who do not initiate quercetin within the first week after their baseline visit.
研究组 & 干预措施
Standard of care (SOC) treatment
Standard of care based on the specific ILD
干预措施: Usual treatment (Drug)
Quercetin (dietary supplement)
干预措施: Quercetin (dietary supplement) (Dietary Supplement)
结局指标
主要结局
Change in Blood Leukocyte Telomere length
时间窗: Baseline, Week 32
Blood leukocyte telomere length will be measured at baseline and after quercetin administration to assess changes associated with the intervention.
Change in FeNO measurement
时间窗: Baseline, Week 32
Fractional exhaled nitric oxide (FeNO) level will be measured at baseline and at Week 32 to assess airway inflammation before and after quercetin administration.
Change in FVC (mL)
时间窗: Baseline, Week 32
Changes from baseline in forced vital capacity (FVC), expressed in milliliters (mL) will be assessed at Week 32.
Change in FVC%
时间窗: Baseline, 32 weeks.
Change from baseline in forced vital capacity (FVC), expressed in percent predicted (FVC%pred), will be assessed at Week 32.
Change in Diffusion Capacity for Carbon Monoxide (DLCO)
时间窗: Baseline, Week 32
Change from baseline in DLCO, expressed as percent predicted (DLCO% pred), will be evaluated at Week 32.
Change in the Senescence-Associated Secretory Phenotype (SASP)
时间窗: Baseline, Week 32
Changes in the Senescence-Associated Secretory Phenotype (SASP) will be assessed by measuring at baseline and at week 32, pro-inflammatory IL- 6, matrix metalloproteinase MMP-7 and KL-6.
次要结局
- Lung Oscillometry R5-R20 measurement(Baseline, Week 32)
- Change in X5 measurement(Baseline, Week 32)
- Change in FEV1 (mL)(Baseline, Week 32)
- Change in FEV1%(Baseline, Week 32)
- Change in KCO(Baseline, Week 32)
- White blood cell (WBC) count(Baseline, Week 32)
- Blood monocyte count(Baseline, Week 32)
研究者
Katerina M. Antoniou
Professor of Respiratory Medicine
University of Crete