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

NCT06288204 | Recruiting DMC

• 1 other identifier: Denise Mafra16
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Hypertension; Cardiovascular Diseases

Keywords

chronic kidney disease; hypertension; cardiovascular disease; inflammation; oxidative stress; green propolis; royal jelly; Nrf2; Nuclear factor kappa-B

Outcome Measures

Primary Outcomes (2)

• Change in factor nuclear kappaB

  Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.

  Baseline and 8 weeks (2 months)

• Change in intestinal microbiota

  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.

  Baseline and 8 weeks (2 months)

Secondary Outcomes (2)

• Change in senescence biomarkers

  Baseline and 8 weeks (2 months)

• Change in uremic toxins

  Baseline and 8 weeks (2 months)

Other Outcomes (2)

• Change in adhesion molecules

  Baseline and 8 weeks (2 months)

• Change in blood pressure

  Baseline and 8 weeks (2 months)

Study Arms (3)

Propolis associated with Royal Jelly Group

EXPERIMENTAL

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.

Dietary Supplement: Propolis associated with Royal Jelly

Royal Jelly

EXPERIMENTAL

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

Dietary Supplement: Royal Jelly

Placebo

PLACEBO COMPARATOR

4 capsules a day of placebo.

Dietary Supplement: Placebo

Interventions

Propolis associated with Royal Jelly DIETARY_SUPPLEMENT

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.

Propolis associated with Royal Jelly Group

Royal Jelly DIETARY_SUPPLEMENT

The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.

Royal Jelly

Placebo DIETARY_SUPPLEMENT

The participant will consume 4 capsules a day of placebo, for 2 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidade Federal Fluminense: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (2)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

RECRUITING

Denise Mafra

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Cardiovascular Diseases; Inflammation

Interventions

royal jelly

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Denise Mafra, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra, PhD

CONTACT

5521985683003; dmafra30@gmail.com

Ludmila Cardozo, PhD

CONTACT

5521987333185; ludmila.cardozo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: October 1, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)