Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Insulin hormone measurement
研究概览
简要总结
Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8 mmol/L after approximately 12 hours fasting. Blood samples were collected in plain tubes before (-5 minutes) and at 1 and 3 hours after drinking pomegranate juice. Blood samples were centrifuged and serum was collected and stored for glucose and hormonal analysis. Patients were recruited from those of earlier stages of type 2 diabetes, and many of them already drink pomegranate juice as of its benefits for their health).
The exclusion criteria included subjects with renal or hepatic disease, pregnancy, treatment with insulin, and hormone therapies. Participants who had either smoked cigarettes or taken antioxidant supplements, lipid-lowering drugs, and oral hypoglycemic agents, such as metformin (glucophage) or sulfonylureas, within the preceding 12 hours were also excluded.
The study was explained to all of the recruited subjects by the clinical researchers, and written informed consent was obtained prior to enrollment. Approval for the study was provided by the IRB Committee at Jordan University of Science and Technology (Irbid, Jordan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes at early stages of progression (Fasting serum glucose: 7.1 - 15.8 mmol/L)
- •Healthy individuals (Fasting serum glucose < 7 mmol/L)
排除标准
- •Subjects with renal
- •Subjects with hepatic disease
- •Pregnant women
- •Subjects under treatment with insulin and any other hormonal therapies
- •Smoking 12 hours before the intervention
- •Antioxidant supplements 12 hours before the intervention
- •Drugs administration: Lipid lowering drugs, oral hypoglycemic agents such as metformin or sulfonylureas 12 hours before the intervention.
研究组 & 干预措施
Patients with type 2 diabetes
Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L)
干预措施: Fresh pomegranate juice (Other)
Healthy individuals
Healthy individuals match age and gender to the experimental group
干预措施: Fresh pomegranate juice (Other)
结局指标
主要结局
Insulin hormone measurement
时间窗: 1 - 3 hours
Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Cortisol hormone measurement
时间窗: 1 -3 hours
Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Fasting serum glucose measurement
时间窗: 1 - 3 hours
Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Erythropoietin hormone measurement
时间窗: 1 - 3 hours
Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Thyroxine hormone measurement
时间窗: 1 - 3 hours
Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion
次要结局
- Testosterone hormone measurement(1 - 3 hours)
- Serum total antioxidant activity measurement(1 - 3 hours)
- Melatonin hormone measurement(1 - 3 hours)
- Aldosterone hormone measurement(1 - 3 hours)
研究者
Saleem A. Banihani
Associate Professor Doctor
Jordan University of Science and Technology