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Набор скоро начнётся NCT07198009

2-HOBA Supplementation in People With Elevated Lipoprotein(a)

Без фазы С лечением Hyperlipidemia Elevated Lp(a)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 2-HOBA (Hobamine).
Кому может быть актуально
Состояния в реестре: Hyperlipidemia, Elevated Lp(a). Базовые параметры: 18 лет — 69 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Modulation of Bioactive Lipids in Lipid Disorders: a Pilot Study of 2-HOBA Supplementation in Individuals With Elevated Lipoprotein(a)

Обзор

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

Подробное описание

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.

Вмешательства

  • Пищевая добавка 2-HOBA (Hobamine)
    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.

Первичные конечные точки

  • Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a) [Срок оценки: 6 weeks]
Вторичные конечные точки (8)
  • High-sensitivity CRP [Срок оценки: 6 weeks]
  • Interleukin-6 [Срок оценки: 6 weeks]
  • Tumor Necrosis Factor-alpha (TNF-α) [Срок оценки: 6 weeks]
  • Fibrinogen [Срок оценки: 6 weeks]
  • D-dimer [Срок оценки: 6 weeks]
  • Thromboxane [Срок оценки: 6 weeks]
  • Platelet aggregation [Срок оценки: 6 weeks]
  • Plasma Lp(a) concentrations [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Lipid Clinic at Brown University Health — Providence

Идентификаторы

NCT: NCT07198009 · 2343236 · 2343236

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗