Characterization of Red Dragon Fruit Peel Powder and Its Potential Role in Improving Vascular Function in Patients With Cardiometabolic Disorders
This study aims to characterize red dragon fruit (Selenicereus undatus) peel powder by evaluating its nutritional, physicochemical, and phytochemical properties. It will also explore its potential role in improving vascular function and cardiometabolic health among patients with cardiometabolic disorders.
Обзор исследования
Статус
Условия
Подробное описание
Cardiometabolic disorders including hypertension, dyslipidemia, and type 2 diabetes are strongly linked with vascular dysfunction, which increases the risk of cardiovascular morbidity and mortality. Conventional pharmacological therapies target metabolic abnormalities but often come with side effects, variable patient compliance, and limited improvement in vascular function. This has generated increasing interest in plant-derived nutraceuticals rich in bioactive compounds with antioxidant and endothelial-protective potential. Red Dragon Fruit (Selenicereus undatus (Haworth) D.R. Hunt) peel, usually considered an agro-waste, contains abundant betalains, flavonoids, dietary fiber, and essential minerals that may improve endothelial nitric oxide bioavailability, reduce oxidative stress, and modulate inflammatory pathways. This study aims to characterize the physicochemical and phytochemical profile of standardized dragon fruit peel powder and evaluate its potential role in improving vascular health in patients with cardiometabolic disorders. The intervention will involve daily supplementation with 4g, 6g and 8g of dragon fruit peel powder provided in a food-based vehicle along with DASH diet to three different groups over a period of 12 weeks. The study will enroll 90 adult participants aged 35-70 years diagnosed with at least one cardiometabolic disorder from CMH Hospital Lahore. Participants will be randomized into an intervention group receiving dragon fruit peel powder or a placebo group. Baseline and post-intervention assessments will include flow-mediated dilation (FMD), blood pressure, fasting glucose, HbA1c, lipid profile, inflammatory markers (hs-CRP, IL-6), and oxidative stress indicators (MDA, TAC). Statistical analysis will be performed using SPSS with significance set at p < 0.05. This study intends to establish Red Dragon Fruit peel as a safe, cost-effective, and sustainable dietary strategy for vascular health improvement and cardiometabolic risk reduction.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: sana noreen, PhD
- Номер телефона: 03018661160
- Электронная почта: sana.noreen@dnsc.uol.edu.pk
Места учебы
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Punjab Province
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Lahore, Punjab Province, Пакистан, 54000
- Sana Noreen
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Контакт:
- sana noreen, PhD
- Номер телефона: 03018661160
- Электронная почта: sana.noreen@dnsc.uol.edu.pk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Both genders (men and women), aged 35-70 years.
- Participants who provide informed consent.
- Participants with BMI ≥ 25.0 kg/m².
- Participants with diagnosed cardiometabolic disorder (type 2 diabetes, hypertension, or dyslipidemia).
- Participants with HbA1c between 6.5-9.0%.
- Participants with fasting plasma glucose 126-200 mg/dL.
- Participants with SBP 130-159 mmHg and/or DBP 80-99 mmHg.
- Participants with Total cholesterol > 200 mg/dL, LDL-C > 130 mg/dL, or HDL-C < 40 mg/dL (men) / < 50 mg/dL (women).
- Participants with Triglycerides > 150 mg/dL.
- Participants with hs-CRP > 3.0 mg/L.
- Participants with measurable IL-6 or MDA above reference range.
- Participants with reduced FMD or elevated PWV/Augmentation Index compared to age norms.
- Participants with liver enzymes (ALT, AST, ALP) ≤2.5× ULN and bilirubin <2× ULN.
- Participants with renal function eGFR ≥ 45 mL/min/1.73m².
- Participants with complete blood count within acceptable clinical range.
- Participants on stable medication doses for ≥8 weeks prior to enrollment.
- Participants willing to follow study diet and physical activity monitoring.
Exclusion Criteria:
- Participants with severe uncontrolled medical conditions such as advanced heart failure, end-stage renal disease, active malignancy, or chronic liver disease will be excluded.
- Individuals currently taking high-dose antioxidant supplements, herbal nutraceuticals, or experimental therapies that may interfere with study outcomes will not be included.
- Pregnant or breastfeeding women will be excluded to avoid potential risks and confounding effects.
- Participants with known allergies or hypersensitivity to dragon fruit or related plant products will not be enrolled.
- Individuals unable or unwilling to consume the Red Dragon Fruit peel powder or adhere to the DASH diet during the intervention period will be excluded.
- Participants with poor compliance history in previous clinical studies or those unable to commit to scheduled follow-ups will not be considered.
- Patients with recent major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months will be excluded.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: PLACEBO T0
Participants will take a standard placebo shot of red dragon fruit accompanied by DASH diet and conventional treatment. |
Participants will take a standard placebo shot of red dragon fruit (Selenicereus undatus (Haworth) D.R. Hunt) accompanied by regular balanced diet and conventional treatment. |
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Экспериментальный: Intervention Group (T₁)
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment |
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment. |
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Экспериментальный: Intervention Group (T₂)
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment. |
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment |
|
Экспериментальный: Intervention Group (T3)
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment. |
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Hypertension
Временное ограничение: 12 weeks
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Blood pressure will be measured in hypertensive patients using a calibrated digital sphygmomanometer and recorded in mmHg after standardized seated rest. |
12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Lipid Profile
Временное ограничение: 12 weeks
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Lipid profile (total cholesterol, triglycerides, HDL-C, and LDL-C) will be assessed using an automated clinical chemistry analyzer, with results expressed in mg/dL |
12 weeks
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Liver Enzymes
Временное ограничение: 12 Weeks
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Liver enzymes (ALT, AST, and ALP) will be measured using an automated clinical chemistry analyzer, with results expressed in U/L. |
12 Weeks
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Fasting Blood glucose
Временное ограничение: 12 Weeks
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Fasting blood glucose will be measured using an automated clinical chemistry analyzer from venous blood samples collected after 8-12 hours of fasting, with results expressed in mg/dL. |
12 Weeks
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- UOL/REB/26/22/03/0014
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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