Disorders of lipoprotein metabolism and other lipidemias
Conditions
Interventions
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 patie
Sponsors
Universidade Estadual do Oeste do Paraná
Universidade Estadual do Oeste do Paraná
Eligibility
Age
36 Years to 56 Years
Inclusion criteria
Inclusion criteria: Candidates of both genders. Must be between 36 and 56 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 six months 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 six months 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 pregnancy during the study (complete abstinence from sexual intercourse that could result in pregnancy is also acceptable). Participants must have veins suitable for repeated venipuncture and be able to swallow tablets or capsules whole without chewing. They must be willing and able to comply with all aspects of the study protocol, including maintaining the same diet and exercise habits throughout the study period. Candidates must also agree not to donate blood or plasma for 30 days after the study’s completion and be capable of providing voluntary consent
Exclusion criteria
Exclusion criteria: Participants who use protease inhibitors that interact with turmeric, reducing the effectiveness of antiretroviral therapy (ART), will not be eligible for the study. Additionally, those who are breastfeeding, pregnant, or planning to become pregnant during the study period will be excluded. Participants with uncontrolled or controlled blood pressure (=140 mmHg systolic or =90 mmHg diastolic) at screening will also be ineligible. Individuals with a history of heart disease, cardiovascular disease, renal or hepatic failure, or who have been diagnosed with any psychiatric disorder, unstable thyroid disease, or cancer (except localized skin cancer without metastasis or cervical cancer in situ) within the last five years prior to screening will be excluded. Furthermore, any other clinically significant condition or disorder that, in the opinion of the investigator, could pose a risk to the participant or influence the study results will prevent their inclusion. Participants who have undergone major surgery with general anesthesia within three months prior to screening or who have major surgery planned during the study will not be eligible. Similarly, those with a history of blood clotting disorders will not be allowed to participate.Individuals who have reported significant blood loss or blood donation totaling between 101 mL and 449 mL within 30 days prior to the first pharmacokinetic visit, or a blood donation of more than 450 mL within 56 days before the first pharmacokinetic visit, will also be excluded. In addition, people with gastrointestinal abnormalities or obstructions that impair swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) will not be eligible for the study. Participants with gallstones, bile duct obstruction, stomach ulcers, excess stomach acid, or gastroesophageal reflux disease will also be excluded. Those with a history of alcohol or substance abuse within 12 months prior to screening, or whose use, in the opinion of the investigator, may compromise their participation in the study, will not be accepted. Finally, individuals with any other active or unstable medical conditions, or who are using medications, supplements, or therapies that could adversely affect the conduct or outcomes of the study, or pose a significant risk to their health, will not be included in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess, through biomarkers, the impact of curcumin supplementation on metabolic parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactLirane Ferreto
Serviço de Assistência Especializada/Centro de Testagem e Aconselhamento (SAE/CTA) de Francisco Beltrão
Outcome results
None listed