Effect of Implementing an Aerobic Training Program and Administering Ginkgo Biloba Extract on Plasma Concentrations of LDL and HDL in HIV Positive Patients Undergoing Antiretroviral Treatment at the HIV Unit of Hospital Civil Fray Antonio Alcalde
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Comparison of changes in serum lipid levels.
研究概览
简要总结
The administration of antiretroviral drugs (ART) has significantly prolonged the life expectancy of people living with human immunodeficiency virus (HIV) and delayed the progression towards Acquired Immune Deficiency Syndrome (AIDS). However, this has led to the emergence of other conditions, such as dyslipidemia, among individuals undergoing ART. Dyslipidemia is commonly managed with statin therapy, which has not been reported to have pharmacological interactions with ART. Additionally, ginkgo biloba extract (GBS) has been observed to improve blood lipid concentrations, and aerobic exercise training (EXA) interventions have shown positive modifications in these values.
Given this context, the present study aims to investigate the potential positive effects of an aerobic training program and the consumption of ginkgo biloba extract on plasma lipid concentrations in HIV-positive individuals. The study seeks to provide insights into novel strategies for managing dyslipidemia in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 60 years
- •Diagnosis of HIV-1 infection
- •Receiving antiretroviral therapy with a triple regimen (Biktarvy treatment)
- •Undetectable viral load (< 20 copies/mL) for the past 6 months CD4+ level > 200 cells/μL
- •Diagnosis of mixed dyslipidemia in the last three months, indicated by:
- •Total cholesterol ≥ 200 mg/dL
- •HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
- •LDL cholesterol > 100 mg/dL
- •Triglycerides ≥ 150 mg/dL
- •Possession of a mobile device or computer with internet access and necessary platforms
- •Willingness to participate voluntarily in the study and provide written consent
排除标准
- •Individuals who develop hypersensitivity or allergy to ginkgo biloba extract
- •Failure to attend at least 80% of the physical exercise sessions (equivalent to missing more than 12 sessions)
- •Lack of adherence to pharmacological treatment
- •Participant's decision to discontinue the intervention
研究组 & 干预措施
Ginkgo biloba group
This group will assess the effects of aerobic exercise combined with ginkgo biloba extract
干预措施: Aerobic exercise + Ginkgo Biloba Extract (Drug)
Placebo group
Participants in this group will serve as a control to evaluate the effects of aerobic exercise when administered a placebo of calcined magnesia
干预措施: Aerobic exercise + Calcined magnesia (placebo) (Drug)
Statins group
In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated
干预措施: Aerobic exercise + Atorvastatin (Drug)
结局指标
主要结局
Comparison of changes in serum lipid levels.
时间窗: 12 weeks
Levels of Total Cholesterol (mg/dL), HDL (High-Density Lipoprotein) (mg/dL), LDL (Low-Density Lipoprotein) (mg/dL), VLDL (Very Low-Density Lipoprotein) (mg/dL) and, Triglycerides (mg/dL) will be assessed
次要结局
未报告次要终点
研究者
Raul Soria Rodriguez, PhD
Associate Research Professor
University of Guadalajara