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

Not Applicable

Recruiting

• Conditions: Hypertension; Cardiovascular Diseases (CVD); Inflammation

• Registration Number: NCT06917131
• Lead Sponsor: Universidade Federal Fluminense

Brief Summary

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.

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 Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-18
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• patients using one to three antihypertensive medications, undergoing regular follow-up at the HUAP Medical Clinic for more than 6 months and without the need for changes in medication doses in the last 3 months.

Exclusion Criteria

• Patients with autoimmune and infectious diseases, diabetes, chronic kidney disease, liver disease, cancer and AIDS will be excluded; pregnant women; those using catabolic drugs or antibiotics; use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotics, habitual intake of royal jelly, and who are allergic to cornstarch or report having an allergy to bee stings will also be excluded. Patients with acute myocardial infarction (AMI) and/or stroke (CVA) in the last 6 months will also be excluded; with HAS stages 2 or 3.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of inflammatory status in the participants	Baseline and 8 weeks	Get blood samples to evaluate the supplementation effects in inflammatory and oxidative stress biomarkers: NfkB, Nrf2, interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), antioxidant enzymes.

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de janeiro, Brazil