Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)
Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Диетическая добавка: Pomegranate extract-first dose-Group A
- Диетическая добавка: Pomegranate extract-first dose-Group B
- Диетическая добавка: Pomegranate extract-second dose-Group A
- Диетическая добавка: Pomegranate extract-second dose-Group B
- Диетическая добавка: Placebo-first dose-Group B
- Диетическая добавка: Placebo-first dose-Group A
- Диетическая добавка: Placebo-second dose-Group B
- Диетическая добавка: Placebo-second dose-Group A
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
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Murcia, Испания, 30107
- UCAM (San Antonio Catholic University from Murcia)
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Pomegranate extract
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Другие имена:
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Другие имена:
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Другие имена:
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Другие имена:
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Плацебо Компаратор: Placebo
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group B will consume 1 daily capsules of placebo for 3 weeks.
Другие имена:
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Другие имена:
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Другие имена:
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in serum oxidized LDL-cholesterol concentration
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on circulating levels of oxidized particles of LDL-cholesterol
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in serum lipids and lipoproteins levels
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in serum sICAM, sVCAM and hsCRP
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in fecal microbiota
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Number of volunteers with adverse events as a measure of safety and tolerability
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in phenolics and derived metabolites in plasma, feces and urine.
Временное ограничение: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Dr. Juan Carlos Espín, PhD, National Research Council (CEBAS-CSIC, Murcia, Spain)
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CEBAS-CSIC-4
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