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NCT Number: NCT07596966

EFFECTS OF PROPOLIS AND ROYAL JELLY SUPPLEMENTATION ON INFLAMMATORY AND OXIDATIVE STRESS MARKERS IN PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION

The study aims to evaluate the effect of the royal jelly and propolis on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.

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Key information

Conditions

Systemic Arterial Hypertension Cardiovascular Diseases Hypertension Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra

Niterói, Rio de Janeiro, 24220-900, Brazil

Location status: Recruiting

Location contact

Ludmila cardozo

CONTACT

[email protected]

+55987333185

About this study

Royal jelly (RG) and propolis (P) are considered superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR and P highlight their potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly and propolis in human populations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of stage 1 and 2 hypertension
  • Regular treatment for more than 6 months
  • There have been no changes in medication doses over the last three months.

Exclusion criteria

  • Autoimmune and infectious diseases, diabetes
  • Chronic kidney disease, liver disease, cancer and AIDS
  • Pregnant women
  • Use of catabolic drugs or antibiotics
  • Use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotic
  • Habitual intake of royal jelly and propolis

Treatment and study plan

Placebo

Dietary Supplement

The placebo group will receive 4 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months.

Royal Jelly + Propolis Group

Dietary Supplement

Participants will receive 4 capsules per day, providing the dosage of 300mg of royal jelly + 500mg propolis for 2 months (8 weeks).

Primary outcomes

  1. Change of inflammatory citokynes

    Time frame: Baseline and 2 months

    Get blood samples to evaluate the supplementation effects in inflammatory cytokines such as interleukin 6 (IL-6, pg/mL), IL-1b (pg/mL), IL-17 (pg/mL) e TNF-α (pg/mL)

Study contacts

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

Denise Mafra, PhD

CONTACT

[email protected]

+5521985683003

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 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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