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

NCT07596966 | Recruiting

• 1 other identifier: Denise Mafra22
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Arterial Hypertension; Inflammation

Keywords

inflammation; royal jelly; propolis; hypertension; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change of inflammatory citokynes

  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)

  Baseline and 2 months

Study Arms (2)

Royal Jelly + Propolis Group

EXPERIMENTAL

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

Dietary Supplement: Royal Jelly + Propolis Group

Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

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.

Placebo Group

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).

Royal Jelly + Propolis 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 and 2 hypertension
• Regular treatment for more than 6 months
• There have been no changes in medication doses over the last three months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Niterói, Rio de Janeiro, 24220-900, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension; Inflammation

Interventions

royal jelly

Condition Hierarchy (Ancestors)

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

Study Officials

• Ludmila Cardozo, PhD

  Universidade Federal Fluminense

  STUDY DIRECTOR

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: May 12, 2026
• First Posted: May 19, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)