Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia
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: Cynacol, Metacol.
- Кому может быть актуально
- Состояния в реестре: Hypercholesterolemia. Базовые параметры: 35 лет — 70 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia
Обзор
The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation. The secondary outcomes are to evaluate: \- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
Подробное описание
In the screening visit subject's demographic data, medical history, co-morbidities and concomitant medication will be collected. Patients with documented hypercholesterolemia (LDL-C values between 115 and 190 mg/dl) will be evaluate. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, fasting plasma glucose (FPG), creatinine, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine phosphokinase (CPK). At the baseline visit, a computerized medical record will be compiled where the following data will be recorded: vital signs \[weight, height, BMI, systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] and the laboratory tests (TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK). The subjects will be randomized in one of the 2 groups to receive Cynacol or Metacol. A sufficient amount of study product for 90 days will be delivered. Standardized diet and physical activity advice will be prescribed. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK. After 45 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. After 90 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation.
The secondary outcomes are to evaluate:
\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
Вмешательства
- Пищевая добавка Cynacol
Cynacol (developed by BioDue S.p.A.) containing, artichoke dry extract, naringin, Silybum marianum dry extract, flaxseed oil, vitamin E and sunflower oil, 2 capsules/day after dinner for 90 days - Пищевая добавка Metacol
Metacol (developed by BioDue S.p.A.) containing coenzyme Q10, monacolin k and flaxseed oil, 2 capsules/day after dinner for 90 days
Первичные конечные точки
- LDL Cholesterol [Срок оценки: 3 months]
Вторичные конечные точки (1)
- Lipid profile parameters different from LDL [Срок оценки: three months]
Критерии участия
Критерии включения
- age between 35-70 years
- both genders
- LDL-C levels between 115 and 190 mg/dl
- subjects able to understand the informed consent and sign it before enrollment in the study
Критерии исключения
- personal history of cardiovascular disease or equivalent risk factors
- Tg levels ≥ 400 mg/dl
- obesity \[body mass index (BMI) ≥ 30 kg/m²\]
- taking hypolipidemic drugs or supplements that affect lipid metabolism
- diabetes mellitus
- known thyroid, liver, kidney or muscle diseases
- any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent
- any known allergy or hypersensitivity to one or more components of the food supplements
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Fondazione IRCCS Policlinico San Matteo — Pavia
Идентификаторы
NCT: NCT07295327 · CYNACOL-METACOL-2025