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临床试验/NCT02119325
NCT02119325已完成不适用

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

GlaxoSmithKline2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年9月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Cmax for Triglyceride in IFG Status Participants
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy overweight male and female participants
  • •Age 18-75 years
  • •BMI ≥25<35 Kg/m2

排除标准

  • •Pregnancy/breast-feeding
  • •Allergy/Intolerance
  • •Anaemic participants: Hb <10g/dL
  • •Diabetic participants: fasting blood glucose >125 mg/dL
  • •Serum Aspartate Transaminase, Alkaline Phosphatase and Serum albumin level 3 times the upper limit of normal range
  • •Participants on other medications (lipid lowering drugs, oral hypoglycemics)

结局指标

主要结局

Cmax for Triglyceride in IFG Status Participants

时间窗: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG

Cmax for Glucose in IFG Status Participants

时间窗: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)

次要结局

  • Cmax for Glucose in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for Glucose in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for Glucose in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Cmax for Triglyceride in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for Triglycerides in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for Triglycerides in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Cmax for RLP Cholesterol in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for RLP Cholesterol in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for RLP Cholesterol in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for RLP Cholesterol in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Cmax for Insulin in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for Insulin in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Cmax for RLP Cholesterol in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for RLP Cholesterol in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for Insulin in IFG Status Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Cmax for Insulin in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • AUC for Insulin in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)
  • Tmax for Insulin in Overweight Healthy Participants(Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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