Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension

May 14, 2026 updated by: Universidade Federal Fluminense
The study aims to evaluate the effect of the royal jelly 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Royal jelly (RG) is considered a 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 highlight its 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 in human populations.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22260050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of stage 1 hypertension
  • Regular treatment for more than 6 months
  • No changes in medication doses during the last 3 months

Exclusion Criteria:

  • Autoimmune diseases
  • Infectious diseases
  • Diabetes
  • Chronic kidney disease
  • Liver disease
  • Cancer
  • AIDS
  • Pregnant women
  • Use of catabolic drugs or antibiotics
  • Use of antioxidant vitamin supplements, prebiotics, probiotics, or synbiotics
  • Habitual intake of royal jelly
  • Allergy to bee stings
  • Acute myocardial infarction (AMI)
  • Stroke (CVA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Royal Jelly Group
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
Dietary supplement: Royal Jelly
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
Placebo Comparator: Placebo Group
The placebo group will receive 2 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.
Dietary supplement: Placebo
The placebo group will receive 2 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of inflammatory transcripton factor
Time Frame: Baseline and 8 weeks
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in interleukin-6 (IL-6) levels
Time Frame: Baseline and 8 weeks
Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation.
Baseline and 8 weeks
Change in tumor necrosis factor-alpha (TNF-α) levels
Time Frame: Baseline and 8 weeks
Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.
Baseline and 8 weeks
Change in Nrf2 expression
Time Frame: Baseline and 8 weeks
Assessment of changes in Nrf2 expression after supplementation.
Baseline and 8 weeks
Change in C-reactive protein (CRP) levels
Time Frame: Baseline and 8 weeks
Assessment of changes in serum C-reactive protein (CRP) levels after supplementation.
Baseline and 8 weeks
Change in antioxidant enzyme activity
Time Frame: Baseline and 8 weeks
Assessment of changes in antioxidant enzyme activity after supplementation.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Investigators

  • Principal Investigator: Ludmila Cardozo, PhD, Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2024

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Denise Mafra21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will not be public to other research unless necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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