TCTR20221102001已完成2 期
The effects of Hibiscus sabdariffa L calyces aqueous extract on insulin resistance in metabolic syndrome volunteers
/A0 个研究点目标入组 108 人开始时间: 2022年11月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Individuals with metabolic syndrome diagnosed by the presence of central obesity (waist circumference greater than 90 cm (men) or greater than 80 cm (women)) and two of the following criteria: (1) fasting triglyceride (TG) level greater than or equal to 150 mg/dl (2) fasting high-density lipoprotein (HDL) cholesterol level 0 - 40 mg/dl (men) or 0 - 50 mg/dl (women) (3) systolic blood pressure greater than or equal to 130 mm Hg or diastolic blood pressure greater than or equal to 85 mm Hg (4) fasting blood glucose 100 - 125 mg/dl
- •2. Non-smoker or quit smoking more than 6 months
- •3. Willing to stop taking dietary supplements which affected study outcomes for 4 weeks prior to study entry
- •4. Individuals who were agreeing to participate in the study and willing to provide written informed consent
排除标准
- •1. Known allergy to Hibiscus sabdariffa
- •2. Consumption of anthocyanin-rich sources during the study (blueberries, strawberries, bilberries, cranberries, elderberries, raspberries, mulberries, grapes, purple sweet potato, red cabbage, eggplant, red radish, pomegranate, rice berry, purple corn, and wine) more than 3 times per week
- •3. Alcohol consumption of more than 1 standard drink per day or more than 7 standard drinks per week (woman) and more than 2 standard drinks per day or more than 14 standard drinks per week (man)
- •4. Individuals with hypertension who are receiving hydrochlorothiazide, losartan, captopril, and amlodipine
- •5. Individuals with dyslipidemia who are receiving statin (simvastatin)
- •6. Individuals who are taking chloroquine
- •7. Individuals with SARS-CoV-2 infection
- •8. Individuals diagnosed with cardiovascular disease, type I and type II diabetes mellitus, and gout
- •9. Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or alkaline phosphatase (ALP) were out of normal range or suffering from hepatic diseases
- •10. Levels of creatinine and/or blood urea nitrogen (BUN) were out of normal range or suffering from kidney disease
- •11. History of cancer
- •12. Women who are pregnant, breast feeding, or planning to become pregnant during the trial, or positive in urine pregnancy test
- •13. Participation in other clinical research trials
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