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NCT Number: NCT06288204

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in factor nuclear kappaB

    Time frame: 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.

  2. Change in intestinal microbiota

    Time frame: 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.

Secondary outcomes

  1. Change in senescence biomarkers

    Time frame: Baseline and 8 weeks (2 months)

    Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53.

  2. Change in uremic toxins

    Time frame: Baseline and 8 weeks (2 months)

    Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS)

Other outcomes

  1. Change in adhesion molecules

    Time frame: Baseline and 8 weeks (2 months)

    Get blood samples to evaluate the supplementation effects Vascular Cell Adhesion Molecule (VCAM).

  2. Change in blood pressure

    Time frame: Baseline and 8 weeks (2 months)

    Evaluate at baseline and 8 weeks the Systolic or Diastolic Blood Pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Mafra, PhD

CONTACT

[email protected]

5521985683003

Ludmila Cardozo, PhD

CONTACT

[email protected]

5521987333185

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 1, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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