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

NCT06917131 | Recruiting

• 1 other identifier: Denise Mafra21
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases (CVD); Inflammation

Keywords

royal jelly; inflammation; Hypertension; cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Change of inflammatory transcripton factor

  Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.

  Baseline and 8 weeks

Secondary Outcomes (5)

• Change in interleukin-6 (IL-6) levels

  Baseline and 8 weeks

• Change in tumor necrosis factor-alpha (TNF-α) levels

  Baseline and 8 weeks

• Change in Nrf2 expression

  Baseline and 8 weeks

• Change in C-reactive protein (CRP) levels

  Baseline and 8 weeks

• Change in antioxidant enzyme activity

  Baseline and 8 weeks

Study Arms (2)

Royal Jelly Group

EXPERIMENTAL

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

Dietary Supplement: Royal Jelly

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Royal Jelly DIETARY_SUPPLEMENT

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

Royal Jelly Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Inflammation

Interventions

royal jelly

Condition Hierarchy (Ancestors)

Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludmila Cardozo, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise mafra, PhD

CONTACT

+5521985683003; dmafra30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: September 18, 2024
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)