NCT07596992

Brief Summary

The aim of this project is to evaluate the effect of bioactive compound sources, propolis and royal jelly, on metabolomics, inflammation, and cardiovascular risk markers in participants with coronary artery disease. A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2028

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Coronary Artery Disease (CAD)Oxidative StressInflammation

Keywords

royal jellypropoliscoronary artery diseaseoxidative stressinflammation

Outcome Measures

Primary Outcomes (1)

  • Change of inflammatory status in the participants

    Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).

    Baseline and 8 weeks

Study Arms (2)

Propolis + Royal jelly Group

EXPERIMENTAL

They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.

Dietary Supplement: Propolis + Royal Jelly

Placebo Group

PLACEBO COMPARATOR

They will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents).

Dietary Supplement: Placebo

Interventions

Propolis + Royal JellyDIETARY_SUPPLEMENT

They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.

Propolis + Royal jelly Group
PlaceboDIETARY_SUPPLEMENT

They will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents).

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes
  • Over 18 years of age;
  • Diagnosed with Coronary Artery Disease: confirmed by coronary angiography, coronary computed tomography angiography, or functional testing with ischemic load);
  • Participants who are asymptomatic or have angina limited to functional class III will be considered;
  • Patients who have already undergone coronary revascularization and angioplasty may participate;
  • the last acute coronary event must have occurred more than one year ago.

You may not qualify if:

  • Unstable Coronary Artery Disease;
  • Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
  • Unstable angina;
  • NYHA functional class III or higher;
  • Advanced chronic kidney disease (creatinine clearance \< 30 ml/min/1.73 m²);
  • Individuals with autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise mafra

Niterói, Rio de Janeiro, 24220-900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery DiseaseInflammation

Interventions

Propolisroyal jelly

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Ludmila Cardozo

    Universidade Federal Fluminense

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra

CONTACT

+5521985683003dmafra30@gmail.com

Ludmila Cardozo

CONTACT

+5521987333185ludmilacardozo@id.uff.br

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

May 12, 2026

First Posted

May 19, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Participant data will not be public to other research unless necessary.

Locations

BR(1)