Association of Green Propolis Extract and Royal Jelly to Modulate Inflammation and Oxidative Stress in Hypertensive Patients and/or With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Change in intestinal microbiota
研究概览
简要总结
This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.
详细描述
Propolis and royal jelly are bee products. Propolis is a resinous mixture produced by bees with their saliva and the addition of wax, from exudates collected from buds and plant sap. Royal jelly is a substance produced in the hypopharyngeal glands of young worker bees. Both products are rich in bioactive compounds such as polyphenols. The combination of propolis extract and royal jelly, substances constituted by the combination of several chemical components with potential biological activity, may emerge as a promising adjuvant therapeutic alternative for patients with CKD and SAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •patients in stages 3 and 5 of CKD (GFR from 15 to 59 mL/min),
- •patients receiving ambulatorial nutrition treatment at least 6 months
- •patients on regular Hemodialysis treatment for at least 6 months
- •patients using one to three antihypertensive drugs
排除标准
- •autoimmune and infectious diseases,
- •pregnant women
- •patients using catabolic drugs or antibiotics;
- •patients with catheter access to hemodialysis;
- •patients using antioxidant vitamin supplements, prebiotics, probiotics, symbiotic,
- •Patients on regular intake of propolis who are allergic to corn starch or report being allergic to bee stings.
- •patients with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA)
研究组 & 干预措施
Propolis associated with Royal Jelly Group
4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months.
干预措施: Propolis associated with Royal Jelly (Dietary Supplement)
Royal Jelly
Royal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
干预措施: Royal Jelly (Dietary Supplement)
Placebo
4 capsules a day of placebo.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in intestinal microbiota
时间窗: Baseline and 8 weeks (2 months)
Stool samples will be collected to evaluate the taxa of bacteria colonizing the intestinal microbiota through short-read sequencing of the V4 region of the RNA ribosomal (rRNA) gene on the Illumina platform.
Change in factor nuclear kappaB
时间窗: Baseline and 8 weeks (2 months)
Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.
次要结局
- Change in senescence biomarkers(Baseline and 8 weeks (2 months))
- Change in uremic toxins(Baseline and 8 weeks (2 months))