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 status in the participants

  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.

  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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

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: August 31, 2025
• Study Completion: December 20, 2025
• Last Updated: April 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)