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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. |
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This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.
Propolis and royal jelly are bee products. Propolis is a resinous mixture produced by bees with their saliva and the addition of wax, from exudates collected from buds and plant sap. Royal jelly is a substance produced in the hypopharyngeal glands of young worker bees. Both products are rich in bioactive compounds such as polyphenols. The combination of propolis extract and royal jelly, substances constituted by the combination of several chemical components with potential biological activity, may emerge as a promising adjuvant therapeutic alternative for patients with CKD and SAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis associated with Royal Jelly Group | Experimental | 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months. |
|
| Royal Jelly | Experimental | Royal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. |
|
| Placebo | Placebo Comparator | 4 capsules a day of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis associated with Royal Jelly | Dietary Supplement | The participants will consume 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in factor nuclear kappaB | Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction. | Baseline and 8 weeks (2 months) |
| Change in intestinal microbiota | Stool samples will be collected to evaluate the taxa of bacteria colonizing the intestinal microbiota through short-read sequencing of the V4 region of the RNA ribosomal (rRNA) gene on the Illumina platform. | Baseline and 8 weeks (2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in senescence biomarkers | Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53. | Baseline and 8 weeks (2 months) |
| Change in uremic toxins | Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adhesion molecules | Get blood samples to evaluate the supplementation effects Vascular Cell Adhesion Molecule (VCAM). | Baseline and 8 weeks (2 months) |
| Change in blood pressure | Evaluate at baseline and 8 weeks the Systolic or Diastolic Blood Pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise Mafra, PhD | Contact | 5521985683003 | dmafra30@gmail.com | |
| Ludmila Cardozo, PhD | Contact | 5521987333185 | ludmila.cardozo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Denise Mafra, PhD | Universidade Federal Fluminense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Recruiting | Rio de Janeiro | Rio de Janeiro | 22260050 | Brazil |
Participant data will not be public to other research unless necessary.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C058787 | royal jelly |
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| Royal Jelly | Dietary Supplement | The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. |
|
| Placebo | Dietary Supplement | The participant will consume 4 capsules a day of placebo, for 2 months. |
|
| Baseline and 8 weeks (2 months) |
| Baseline and 8 weeks (2 months) |
| Denise Mafra | Recruiting | Rio de Janeiro | Rio de Janeiro | Brazil |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |