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

NCT06917131 · Universidade Federal Fluminense
In plain English

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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.
Eligibility criteria
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)
Study design
Enrollment target: 34 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-09-18
Estimated completion: 2026-12-10
Last updated: 2026-05-19
Interventions
Dietary Supplement: Royal JellyDietary Supplement: Placebo
Primary outcomes
  • Change of inflammatory transcripton factor (Baseline and 8 weeks)
Sponsor
Universidade Federal Fluminense · other
Contacts & investigators
ContactDenise mafra, PhD · contact · dmafra30@gmail.com · +5521985683003
InvestigatorLudmila Cardozo, PhD · principal_investigator, Universidade Federal Fluminense
All locations (1)
Denise MafraRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension · TrialPath