跳至主要内容
临床试验/NCT06394531
NCT06394531尚未招募不适用

Jaboticaba (Plinia Cauliflora) as a Strategy to Modulate Inflammation, Oxidative Stress, and Gut Dysbiosis in Patients With Chronic Kidney Disease

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Primary Outcome Measure

研究概览

简要总结

The increase prevalence of chronic kidney disease (CKD) over the years represent a significant public health problem. The role of inflammation and oxidative stress in the pathophysiology of CKD, as well as progression and comorbidities, is already well consolidated. The gut microbiota composition imbalance may also be a risk factor contributing to the increased conditions mentioned above, and to uremic toxins release and endotoxemia. The literature has indicated the use of bioactive compounds as a nonpharmacological treatment strategies for the management of non-communicable diseases (NCDs), such as CKD and its complications. In this context, jaboticaba (Plinia Cauliflora) emerges as a potential therapeutic approach as it is a source of phenolic compounds, such as anthocyanins, flavonols, ellagitannins, and phenolic acids. Such phenolic compounds may have beneficial effects in patients with CKD, such as anti-inflammatory, antioxidant, modulation of the intestinal microbiota, hypotensive and hypoglycemic effects. These combined effects can help manage risk factors and CKD itself, and associated complications. Therefore, this research project aims to add scientific knowledge, providing a non-pharmacological therapeutic approach to be implemented in clinical practice and in the care of patients with CKD, with the aim of modulating inflammation, oxidative stress, microbiota composition, and improving the quality of life of these patients. Therefore, this study aims to evaluate the effects of jaboticaba (Plinia Cauliflora) supplementation on complications associated with CKD.

详细描述

This is a chronic study, which consists of a longitudinal, randomized, double-blind, crossover clinical study, with a washout period and placebo-controlled trial. Thirty patients with CKD undergoing hemodialysis will be selected (according to sample calculation, considering p=0.05 and test power of 80%). Randomization will be computerized in a 1:1 ratio, with a block size of 15 (Jaboticaba and Control groups), to receive jaboticaba peel extract or placebo. Eligible patients of both genders, previously evaluated and authorized by the medical and nutritionist team, will be invited to participate in the research in person and verbally, during nutritional consultations at the Prodoctor Hemodialysis Clinic. The intervention consists of supplementing 4 capsules/day, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, or the same amount of placebo, corn starch, for one month. After the end of this first intervention, blood and fecal samples will be collected again. Followed by a 2-month washout period. After 2 months, blood and fecal samples will be collected again from these patients. The crossover will then begin, the second moment of supplementation in which the patients who received the jaboticaba peel extract in the first moment start to receive the placebo, and the patients who received the placebo initially began to receive jabuticaba peel extract supplementation for one month. At the end of the second supplementation period, blood and fecal samples will be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 75 years
  • Clinical diagnosis of Chronic Kidney Disease
  • Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months
  • Hemodialysis group: Hemodialysis patients for more than 6 months

排除标准

  • Patients pregnant
  • Using antibiotics in the last 3 months
  • Autoimmune diseases
  • Clinical diagnosis of infectious diseases
  • Clinical diagnosis of Cancer
  • Clinical diagnosis of AIDS

研究组 & 干预措施

Intervention

Active Comparator

Jaboticaba peel extract. Patients will ingest 4 capsules/day of jaboticaba (Plinia Cauliflora) peel extract, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, for one month.

干预措施: Jaboticaba Peel Extract (Dietary Supplement)

Placebo

Placebo Comparator

Placebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month.

干预措施: Placebo (Other)

结局指标

主要结局

Primary Outcome Measure

时间窗: 4 weeks

Antioxidant and anti-inflammatory biomarker Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)

Inflammatory biomarker

时间窗: 4 weeks

Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)

Microbiota Composition

时间窗: 4 weeks

Get fecal samples to evaluate the supplementation effects in microbiota composition.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验