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NCT Number: NCT06917131

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Cardiovascular Diseases (CVD) 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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Royal Jelly

Dietary Supplement

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

Placebo

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in Nrf2 expression

    Time frame: Baseline and 8 weeks

    Assessment of changes in Nrf2 expression after supplementation.

  4. 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.

  5. Change in antioxidant enzyme activity

    Time frame: Baseline and 8 weeks

    Assessment of changes in antioxidant enzyme activity after supplementation.

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
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
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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