RecruitingNot ApplicableNCT06917131

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


Sponsor

Universidade Federal Fluminense

Enrollment

34 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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.

Interventions

DIETARY_SUPPLEMENTRoyal Jelly

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

DIETARY_SUPPLEMENTPlacebo

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.


Locations(1)

Denise Mafra

Rio de Janeiro, Brazil

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NCT06917131


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