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

Universidade Federal Fluminense

Status: Enrolling

Conditions: Hypertension; Chronic Kidney Diseases; Cardiovascular Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Propolis associated with Royal Jelly; Dietary Supplement: Royal Jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT06288204

Denise Mafra16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 3 patient groups, including a placebo group

Propolis associated with Royal Jelly Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Propolis associated with Royal Jelly

Royal Jelly

Experimental group

Description:

Royal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.

Treatment:

Dietary Supplement: Royal Jelly

Placebo

Placebo Comparator group

Description:

4 capsules a day of placebo.

Treatment:

Dietary Supplement: Placebo