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临床试验/NCT03897517
NCT03897517Unknown不适用

Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption in Overweight, Insulin Resistant Adult Men and Women

Plexus Worldwide0 个研究点目标入组 30 人开始时间: 2019年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Post Prandial Glycemia

研究概览

简要总结

This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source.

详细描述

Type 2 diabetes is a metabolic disorder characterized by elevated fasting blood glucose and impaired insulin signaling (insulin resistance) and is associated with several comorbidities including neuropathy, retinopathy, kidney disease, and elevated risk for heart attack and stroke. Lifestyle interventions targeted towards prevention of type 2 diabetes include: maintaining and achieving healthy bodyweight, physical activity, avoiding tobacco use, and reducing sugar and saturated fat intake. The International Scientific Consensus Summit from the International Carbohydrate Quality Consortium indicated that diets low in glycemic index and glycemic load were important in the prevention and management of diabetes. Health supplements that can lower the glycemic index and glycemic load of food have potential to support the prevention of diabetes and improve blood glucose management by reducing post prandial glycemia and insulinemia. This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source. This proposal will fill a void in the literature by testing for the first time the effect of a combination of mulberry leaf, white kidney bean extract and cinnamon on postprandial carbohydrate absorption and glucose control in overweight, insulin resistant men and women. This project will provide pilot data to support larger studies, and studies to investigate long-term effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Treatment and placebo will be matched closely in color and appearance administered in a double blinded fashion as provided by the material supplier.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-65 years
  • Men and women
  • Able to provide written consent in English
  • A body mass index between 23.0 and 30.0 kg/m2
  • A fasting serum blood glucose level between 100.0 and 126.0 mg/dL

排除标准

  • Current smoker
  • Having a BMI less than 23.0 kg/m2 and higher than 30.0 kg/m2
  • Having a fasting blood glucose level less than 100.0 mg/dL and higher than 126.0 mg/dL
  • Suffering from known serious cardiac, hepatic, renal, pulmonary, gastrointestinal, endocrine or hematological disease based on investigator determination, aside from pre-diabetes
  • Currently pregnant or breastfeeding
  • Consuming more than 2 alcoholic drinks per day on average.
  • Weight loss of more than 5% of body weight over the past 6 months

研究组 & 干预措施

Proprietary Botanical Blend

Experimental

Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules

干预措施: Proprietary Botanical Blend (Dietary Supplement)

Placebo

Placebo Comparator

Non/minimally nutritive nonactive material: rice flour. 2 capsules

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Post Prandial Glycemia

时间窗: 3 weeks

Plasma glucose concentrations after the ingestion of a high carbohydrate meal

Breathe hydrogen concentration

时间窗: 3 weeks

Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption

次要结局

未报告次要终点

研究者

发起方
Plexus Worldwide
申办方类型
Industry
责任方
Sponsor

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