Evaluation of Pre-meal Load of Raw Almonds on Postprandial Hyperglycemia and Other Metabolic Responses in Asian Indians With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)]
研究概览
简要总结
A few studies show the effect of almonds on postprandial hyperglycemia (PPHG); high blood glucose after meals. In our previous study on intervention with almonds, we observed a significant decrease in HbA1C and a small decrease in fasting blood glucose indicating a possible effect of almonds on PPHG. Studies have shown that a preload of a food article that is high in protein, mono-unsaturated fatty acids, fiber, and low in carbohydrates, such as almonds could be helpful in stimulating insulin secretion and help improve postprandial hyperglycemia. The proposed study shall be undertaken to assess the effect of almond supplementation on postprandial hyperglycemia in Asian Indians with prediabetes.
详细描述
- Acute Phase Study: Randomized controlled cross over study design Number of arms: 2, almond and control, n=60 needed (30 in each arm) Subjects randomized to almonds arm are given a preload of 20 g of almonds 30 minutes prior to ingestion of 75 g of glucose, while those in the control arm do not have any food/almonds before OGTT. Blood samples are collected at (minutes): -30, 30, 0, 30, 60, 90 and 120. Cross over of these subjects is done and OGTT repeated in a similar manner. Assessment of blood glucose, serum insulin, glucagon, C-peptide, serum triglycerides, free fatty acids, DPP-IV, and GLP1 levels are done at these time points.
- Sub-Acute Study:
Three-day almond preload study monitored with CGMS, n=60 needed. All study participants undergoing OGTT are further studied with CGMS for three days each and then crossed over. Those in almonds arm continue to receive preload of almonds (20g almonds, 30 minutes before breakfast, lunch and dinner)for three days and then studied without almond preload after cross over. A washout period of 7 days separates cross-over period.
o Chronic Phase Study: Ninety days almond preload study monitored with self-monitoring of blood glucose; n=60 needed.
This is a randomized controlled parallel-arm study to evaluate the long-term effect of preload of almonds on hyperglycemia. Subjects fulfilling the inclusion/exclusion criteria are randomized to either the control arm or the almond arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 60 years
- •Prediabetes as diagnosed on oral glucose tolerance test (OGTT): Fasting blood glucose ≥100mg/dl and <126 mg/dl and 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 gram anhydrous oral glucose) or 2-h plasma glucose
- •140mg/dl and <200mg/dl alone.
排除标准
- •Acute infections and advanced end-organ damage
- •History of hepatitis or pancreatitis, abnormal liver and renal functions
- •Recent (<3 months) changes in weight (≥5%) and/or weight changing medications
- •Any known allergy to nuts
- •uncontrolled hypertension or hypothyroidism
- •suffering from acute infection or any debilitating disease or with renal failure
研究组 & 干预措施
treatment
premeal load of almonds
干预措施: almonds (Dietary Supplement)
control
standard diet
结局指标
主要结局
Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)]
时间窗: 8 days
次要结局
- postprandial blood glucose levels [AUC 0-4 hrs on continuous glucose monitoring system{CGMS}](15 days)
- Postprandial hyperglycaemia (blood glucose levels 2 hrs post OGTT)(3 months)