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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal Fluminense

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Autoimmune and infectious diseases, diabetes

Chronic kidney disease, liver disease, cancer and AIDS

Pregnant women

Use of catabolic drugs or antibiotics

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Royal Jelly + Propolis GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
Baseline and 2 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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