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临床试验/NCT02615444
NCT02615444Unknown不适用

An Investigation of the Effects of Consuming Oatcakes Containing 4g of Oat Beta-glucan on Physiological Parameters in Individuals at Risk of Developing Metabolic Syndrome

Queen Margaret University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Waist Circumference

研究概览

简要总结

The purpose of this study is to determine whether daily consumption of soluble fibre, oat beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

详细描述

The purpose of this study is to determine whether daily consumption oat beta glucan (4g) for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

Oat beta-glucan has been incorporated into a novel oatcake product manufactured by Nairn's Oatcakes Ltd. Consumption of the oatcake products will deliver enough oat-beta glucan to the diet to meet European Food Safety Authority health claims for lowering blood cholesterol and reducing post-prandial glycaemic responses.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Males and females 18 years and older
  • Waist circumference measurements of ≥94cm for males and 80cm for females, or a body mass index of ≥30kg/m2
  • Individuals who are able to provide informed consent

排除标准

  • Postmenopausal females
  • Individuals who suffer from, or taking medication for, cardiovascular or gastro-intestinal disease
  • Impaired glucose tolerance/Diabetes mellitus
  • Pregnancy or breastfeeding
  • Those who have high dietary fibre intakes (>20g/day)
  • Known food allergies to oats, wheat, lactose, or sesame seeds

结局指标

主要结局

Waist Circumference

时间窗: 6 weeks

次要结局

  • Fasting Serum Triglycerides(6 weeks)
  • Fasting Serum total Cholesterol(6 weeks)
  • Interleukin-6(6 weeks)
  • Blood Pressure(6 Weeks)
  • Fasting Serum HDL Cholesterol(6 Weeks)
  • Oral Glucose Tolerance Test(6 weeks)
  • Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Zaremba

PhD Student

Queen Margaret University

研究点 (2)

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