The Benefits of Curcumin Supplementation in Individuals with HIV/AIDS

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2024
INTERVENTION: We are conducting a randomized, double‐blind, crossover clinical trial to evaluate the effects of Curcumin supplementation on dyslipidemia in individuals with HIV. The sample size consists of 42 patients, divided into two groups of 21 patients each. Data will be collected through interviews conducted in the outpatient clinic, either before or after medical and/or nursing consultations. The interviews are expected to last approximately 30 minutes and will be conducted by the principal researcher and trained research assistants. Sociodemographic and clinical data, alcohol consumption, level of physical activity, dietary patterns, anthropometric measurements, and lean body mass by bioimpedance will be collected. Fasting blood samples will be collected from a cubital vein at the beginning, 12th week, 16th week, and end of the study. The intervention group will receive 1000 mg of Curcumin powder (two 500 mg capsules of Curcumin after main meals), while the placebo group will receive 1000 mg of corn starch as a placebo (two 500 mg capsules after main meals) daily for 12 weeks. Subsequently, a 30‐day washout period will be implemented, and the groups will be reversed. Participants will be asked not to make any special changes to their diet and physical activity and to report any changes in medication during the intervention period. The only intervention performed will be supplementation with Curcumin or placebo. CONDITION: Disorders of lipoprotein metabolism and other lipidemias PRIMARY OUTCOME: To assess, through biomarkers, the impact of curcumin supplementation on metabolic parameters. SECONDARY OUTCOME: Evaluation of the relationship between curcumin supplementation and cytokine levels and oxidative stress. Incidence of adverse events in intervention participants over 90 days. ; Number of participants who experienced adverse events related to the use of curcumin. ; Total count of treatment‐related adverse events over 90 days. INCLUSION CRITERIA: Candidates of both genders. Must be between 40 and 50 years old and be aware of their serological status, regardless of the stage of infection. They are required to have been on continuous antiretroviral therapy for more than si Xmonths and be under clinical follow‐up at the Specialized Care Service. Candidates should have a normal or investigator‐acceptable heart rate during screening. Individuals with the potential to become pregnant must present a negative pregnancy test at the beginning of the study and agree to use an acceptable form of non‐hormonal birth control throughout the study period (this includes methods such as double barrier, non‐hormonal intrauterine devices, complete abstinence from sexual intercourse that could result in pregnancy, or partner vasectomy performed at least si Xmonths before the first dose of the study product). Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregna
Epistemonikos ID: bea9768b756940948573c00215673dec8551671c
First added on: Feb 25, 2025