Coronary Artery Disease (CAD), Inflammation, Oxidative Stress
Conditions
Keywords
ginger, coronary artery disease, inflammation, oxidative stress
Brief summary
The study aims to evaluate the effect of ginger supplementation on inflammatory cytokines and markers of oxidative stress in patients with Coronary Artery Disease (CAD). A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.
Detailed description
Ginger (Zingiber officinale Roscoe) contains phenolic compounds, such as gingerols, shogaols, and zingiberene, recognized for their antioxidant and anti-inflammatory properties, and may act as an adjuvant strategy in the prevention and management of CAD. However, there are no studies in CAD patients evaluating these data.
Interventions
DIETARY_SUPPLEMENTGinger
Participants will receive 2 capsules per day, providing the ginger extract daily, at a dosage of 500mg.
DIETARY_SUPPLEMENTPlacebo
The placebo group will receive the same amount of 500mg placebo, at the same time, containing corn starch.
Sponsors
Universidade Federal Fluminense
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of inflammatory status in the participants | Baseline and 8 weeks | 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). |
Countries
Brazil
Contacts
CONTACTDenise Mafra
CONTACTLudmila Cardozo
PRINCIPAL_INVESTIGATORLudmila cardozo
Universidade Federal Fluminense
Outcome results
None listed