Modulation of Bioactive Lipids in Lipid Disorders: a Pilot Study of 2-HOBA Supplementation in Individuals With Elevated Lipoprotein(a)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a)
研究概览
简要总结
The goal of this clinical trial is to learn if a natural supplement called 2-hydroxybenzylamine (2-HOBA) can reduce harmful oxidized lipids and improve the function of lipoprotein(a) in adults with high lipoprotein(a) levels.
The main questions it aims to answer are:
Does 2-HOBA lower oxidized phospholipids on lipoprotein(a)? Does 2-HOBA reduce markers of inflammation and blood clotting in the blood?
Participants will:
Take 2-HOBA capsules (400 mg, three times daily with meals) for 6 weeks Provide blood and urine samples at the beginning, middle, and end of the study Have lab tests to measure changes in lipids, inflammation, and clotting markers
详细描述
Lipoprotein(a), or Lp(a), is a genetically determined cholesterol particle that increases the risk of heart disease and stroke. High levels of Lp(a) affect about 1 in 4 people, and there are no approved treatments that directly reduce its harmful effects. One reason Lp(a) is thought to be harmful is that it carries oxidized phospholipids, which promote inflammation and blood clotting.
2-hydroxybenzylamine (2-HOBA, also known as Hobamine) is a naturally occurring compound that neutralizes reactive molecules responsible for forming oxidized lipids. Preclinical studies and early human trials suggest that 2-HOBA is safe and may lower the buildup of oxidized phospholipids.
This pilot clinical trial will test whether oral 2-HOBA supplementation can improve the biology of Lp(a) in people with high levels (≥90 mg/dL). Ten adults will take 2-HOBA (400 mg by mouth, three times daily with meals) for 6 weeks. Blood and urine will be collected at three clinic visits (baseline, mid-study, and end of study). Researchers will measure oxidized phospholipids, lipoprotein function, markers of inflammation (such as C-reactive protein and interleukins), and markers of clotting (such as fibrinogen, D-dimer, and platelet activity).
The results will provide early information about whether 2-HOBA can reduce harmful changes linked to high Lp(a) and help guide the design of larger future trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-69 years.
- •Elevated Lp(a) levels ≥ 90 mg/dL.
- •Able to provide informed consent and adhere to study schedules.
- •Willing to follow a physician-recommended diet during the study.
排除标准
- •Pregnant, planning pregnancy during the study period, or currently breastfeeding.
- •Individuals with established cardiovascular disease
- •Planning major changes in diet or exercise routines.
- •Experienced >20% weight change in the past 3 months.
- •Diagnosed with malabsorption syndrome or chronic diarrhea.
- •Abnormal liver, kidney, or thyroid function.
- •Drug or alcohol abuse within the past 6 months, or significant mental/psychological impairment.
- •Have known bleeding disorders (e.g., hemophilia).
- •Planned surgery during the study period.
- •Donated blood within the last 2 weeks or planning to donate during the study.
- •Require regular blood transfusions.
结局指标
主要结局
Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a)
时间窗: 6 weeks
OxPL levels on circulating lipoprotein(a) will be measured in blood samples collected before and after 6 weeks of oral 2-HOBA supplementation.
Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a)
时间窗: 6 weeks
OxPL levels on circulating lipoprotein(a) will be measured in blood samples collected before and after 6 weeks of oral 2-HOBA supplementation.
次要结局
- High-sensitivity CRP(6 weeks)
- Interleukin-6(6 weeks)
- Tumor Necrosis Factor-alpha (TNF-α)(6 weeks)
- Fibrinogen(6 weeks)
- D-dimer(6 weeks)
- Thromboxane(6 weeks)
- Platelet aggregation(6 weeks)
- Plasma Lp(a) concentrations(6 weeks)
- High-sensitivity CRP(6 weeks)
- Interleukin-6(6 weeks)
- Tumor Necrosis Factor-alpha (TNF-α)(6 weeks)
- Fibrinogen(6 weeks)
- D-dimer(6 weeks)
- Thromboxane(6 weeks)
- Platelet aggregation(6 weeks)
- Plasma Lp(a) concentrations(6 weeks)