Effect of pistachios on dietary glycemic load,cardiometabolic risk factors, and the gut microbome among Asian Indian adults with pre-diabetes-A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in 1) fasting glucose, 2) 2hour post glucose load;
研究概览
简要总结
Indiandiets are high in GL mainly derived from the 3 meals, a positive study outcome wouldhelp to provide evidence that as little as 30g of roasted pistachio in eachday’s breakfast and dinner over 12 weeks could help to reduce GL in Indiandiets. Indian diets are also deficient in MUFA with the current intake of 6.9%E(median) providing only half of the recommended intake. Addition of 60g ofpistachio providing 11.4g of MUFA could increase the MUFA calories to 11%E. Thiswill support the hypothesis that replacing carbohydrates with pistachio (with goodquality of fat especially MUFA) would not only reduce the metabolic risk but alsoimprove the overall quality of the Asian Indian diet as pistachios are a richsource of protein, MUFA and other phytonutrients that are currently low in Indiandiets. In addition, intake of 60g roasted pistachio per day will help toimprove the daily intake of PUFA particularly n3-PUFA, alpha linolenic acid (ALNA)intake by about 15-17%.
This studywill give an insight on the efficacy of roasted pistachios on modulating cardiometabolicrisk and especially glucose and insulin related parameters. This will then be asimple dietary tool for physicians, dietitians and other health careprofessionals to promote and enable improved dietary adherence and a betterstrategy to reduce the risk of diabetes by reducing the metabolic risk factorsfor diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Hypertension Pre-diabetes (Impaired fasting glucose: fasting capillary blood glucose ≥110mg/dl and <126mg/dl and/or Impaired glucose tolerance: plasma glucose 2-hrs post after 75g glucose load ≥140mg/dl but <200mg/dl).
排除标准
- •Self-reported diabetes Current daily and weekly tobacco users History of allergy to nuts Patients on oral steroids, metformin, on hormonal replacement therapy History of bariatric surgery or have underwent any major surgery in last 6 months Use of nutritional supplements Bad dentures Patients with cancer, Patients on medications for psychiatric disorders, Active weight loss (more than 3 kg in the last month) •Pregnant/lactating women Presence of severe liver, kidney, thyroid, or other endocrine diseases Any condition that hinders compliance to the intervention.
- •Possible eating disorder.
结局指标
主要结局
Changes in 1) fasting glucose, 2) 2hour post glucose load;
时间窗: 2 time points | 1.Baseline-at the time of study commencement | 2.End- at the end of 3 months
次要结局
- Changes in(Insulin resistance measured by HOMA-IR)