Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD
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: Taiwanese green propolis, placebo.
- Кому может быть актуально
- Состояния в реестре: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Базовые параметры: 18 лет — 80 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study investigates the effectiveness of Taiwanese green propolis in reducing blood lipids and body fat in sub-healthy individuals. The study design follows a parallel, double-blind, randomized assignment approach, dividing participants into an experimental group (propolis) and a control group (placebo). Researchers explained the study plan to participants, and after obtaining signed informed consent, participants were randomly assigned using a web-based program that generated random serial numbers. The randomization was stratified by gender (male-to-female ratio of 1:1) and physiological age groups (maturity, middle age, menopause, post-menopause, and old age). Serial numbers and group assignments were sequentially encoded and placed in opaque, consecutively numbered envelopes. After obtaining consent, researchers opened the sealed envelopes in order and assigned participants to either the experimental group (propolis) or the control group (placebo), with 30 participants in each group. The experimental group received Taiwanese green propolis (which can be stored at room temperature) in capsule form, containing 500 mg/ml of propolis extract per capsule. Participants took two capsules before breakfast and two before dinner, totaling four capsules per day for 12 weeks. The control group received a placebo with the same dosage and administration method. All participants were instructed not to deliberately change their daily diet or exercise routines during the study. To assess adherence, participants recorded their daily propolis capsule intake. Additionally, the Health Belief Model questionnaire and the EQ-5D-5L quality of life questionnaire were used to evaluate whether the intervention with propolis, along with dietary and exercise education, contributed to increased awareness of health behaviors and improvements in quality of life. The primary outcomes of the study include changes in blood lipids, body fat, blood glucose levels, liver fat, and liver fibrosis. The secondary outcomes focus on the correlation between health behavior awareness and quality of life. Keywords: Taiwanese green propolis, sub-health, blood lipids, body fat, Health Belief Model, quality of life.
Подробное описание
Inclusion and Exclusion Criteria
Inclusion Criteria:
Aged 18 to 80 years.
Meet any of the following dyslipidemia indicators:
Total cholesterol (TC) \> 200 mg/dL
Triglycerides (TG) \> 200 mg/dL
LDL cholesterol \> 130 mg/dL
Overweight or obese (BMI ≥ 27) with abnormal waist circumference:
Male \> 90 cm
Female \> 80 cm
Not currently receiving any lipid-lowering medication treatment.
Exclusion Criteria:
Allergic to honey, propolis, various pollens, or alcohol.
Individuals with psychiatric disorders or cognitive impairments.
Pregnant or breastfeeding women.
Individuals with significant endocrine disorders or major diseases of the heart, liver, kidneys, or other organs.
Individuals with swallowing difficulties.
Individuals with dementia, impaired consciousness, or other cognitive disorders preventing informed consent.
Individuals already receiving formal lipid-lowering drug therapy.
Individuals with comorbid diabetes, chronic kidney disease, or isolated LDL \> 190 mg/dL.
Вмешательства
- Пищевая добавка Taiwanese green propolis
Intervention Details: Experimental Group: Take two capsules of Taiwan Green Propolis (each containing 500 mg/mL of propolis) before breakfast and dinner daily, totaling four capsules/day for 12 consecutive weeks. During the intervention period, both groups will maintain their usual diet and activity levels and receive the same health education on nutrition and exercise. - Пищевая добавка placebo
Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.
Первичные конечные точки
- In body [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- Changes in blood lipids [Срок оценки: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- fatty liver status [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
Вторичные конечные точки (7)
- Eating Behavior Scale [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- quality of life Questionnaire Assessments [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- gut microbiota [Срок оценки: Collected at baseline and Week 12 to assess gut microbiota changes]
- inflammatory markers [Срок оценки: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- health beliefs [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- ESAS Fatigue Scale [Срок оценки: Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends]
- IPAQ [Срок оценки: Baseline (bWeek 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends efore intervention)]
Критерии участия
Критерии включения
Aged 18 to 80 years.
Meet any of the following dyslipidemia indicators:
Total cholesterol (TC) > 200 mg/dL
Triglycerides (TG) > 200 mg/dL
LDL cholesterol > 130 mg/dL
Overweight or obese (BMI ≥ 27) with abnormal waist circumference:
Male > 90 cm
Female > 80 cm
Not currently receiving any lipid-lowering medication treatment. MASLD
Критерии исключения
- Allergic to honey, propolis, various pollens, or alcohol.
Individuals with psychiatric disorders or cognitive impairments.
Pregnant or breastfeeding women.
Individuals with significant endocrine disorders or major diseases of the heart, liver, kidneys, or other organs.
Individuals with swallowing difficulties.
Individuals with dementia, impaired consciousness, or other cognitive disorders preventing informed consent.
Individuals already receiving formal lipid-lowering drug therapy.
Individuals with comorbid diabetes, chronic kidney disease, or isolated LDL > 190 mg/dL.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital — Chiayi City
Идентификаторы
NCT: NCT07114926 · A11303004 · A11303004 · N202305017