Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease

Официальное название

Association of Green Propolis Extract and Royal Jelly to Modulate Inflammation and Oxidative Stress in Hypertensive Patients and/or With Chronic Kidney Disease

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Propolis associated with Royal Jelly
  The participants will consume 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.
• Пищевая добавка Royal Jelly
  The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
• Пищевая добавка Placebo
  The participant will consume 4 capsules a day of placebo, for 2 months.

Первичные конечные точки

• Change in factor nuclear kappaB [Срок оценки: Baseline and 8 weeks (2 months)]
• Change in intestinal microbiota [Срок оценки: Baseline and 8 weeks (2 months)]

Вторичные конечные точки (2)

• Change in senescence biomarkers [Срок оценки: Baseline and 8 weeks (2 months)]
• Change in uremic toxins [Срок оценки: Baseline and 8 weeks (2 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• autoimmune and infectious diseases,
• diabetes
• cancer
• AIDS
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 2 центра

• Denise Mafra — Rio de Janeiro
• Denise Mafra — Rio de Janeiro

Идентификаторы

NCT: NCT06288204 · Denise Mafra16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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