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| ID | Type | Description | Link |
|---|---|---|---|
| 2343236 | Other Grant/Funding Number | Internal Grant |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-HOBA Supplementation for Elevated Lipoprotein(a) | Experimental | Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine) at a dose of 400 mg three times daily with meals for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-HOBA (Hobamine) | Dietary Supplement | Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine), a dietary supplement with Generally Recognized as Safe (GRAS) status. The study dose is 400 mg three times daily with meals for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a) | OxPL levels on circulating lipoprotein(a) will be measured in blood samples collected before and after 6 weeks of oral 2-HOBA supplementation. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| High-sensitivity CRP | High-sensitivity CRP will be measured in blood samples to assess changes in systemic inflammation after 2-HOBA supplementation. | 6 weeks |
| Interleukin-6 | IL-6 levels will be measured in plasma to evaluate the effect of 2-HOBA on inflammatory signaling. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenliang Song, MD | Contact | 4014449851 | wsong@brownhealth.org | |
| Daria Salamevich | Contact | 4014449857 | dsalamevich@brownhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Wenliang Song, MD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lipid Clinic at Brown University Health | Providence | Rhode Island | 02914 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C032416 | 2-(aminomethyl)phenol |
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| 6 weeks |
| Tumor Necrosis Factor-alpha (TNF-α) | TNF-α concentrations will be measured in plasma as an additional marker of inflammation. | 6 weeks |
| Fibrinogen | Plasma fibrinogen levels will be measured to assess changes in blood clotting potential. | 6 weeks |
| D-dimer | D-dimer will be measured in plasma as a marker of fibrinolysis and thrombosis. | 6 weeks |
| Thromboxane | Urinary and plasma thromboxane B2 will be analyzed to evaluate platelet activation. | 6 weeks |
| Platelet aggregation | Platelet aggregation will be measured using agonists such as arachidonic acid, ADP, and collagen. | 6 weeks |
| Plasma Lp(a) concentrations | Plasma Lp(a) concentrations will be measured to monitor any effects of 2-HOBA on lipoprotein levels. | 6 weeks |