跳至主要内容
临床试验/NCT01898026
NCT01898026Unknown不适用

Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
试验地点
2
主要终点
Sensory Evaluation

研究概览

简要总结

The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. A sensory evaluation will be conducted in phase I to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test foods from phase I.

详细描述

Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.

This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.

35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.

An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.

研究设计

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

入排标准

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

入选标准

  • Normotensive (SBP<140mmHg, DBP <90mmHg)
  • BMI 18.5 - 25 kg/m2
  • Post-menopausal or not pregnant women

排除标准

  • Allergy or sensitivity to test meals
  • Swallowing difficulties
  • Chronic use of medications or fibre
  • GI conditions affecting stomach pH
  • Must not be enrolled in another study
  • History of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, HIV positive or AIDS

结局指标

主要结局

Sensory Evaluation

时间窗: 1 month

Subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.

Postprandial Glycemia

时间窗: 3 months

Subjects will be randomized to consume one of the 8 interventions at each visit and blood glucose levels over 120min and satiety scores will be measured.

次要结局

  • Satiety Score(3 months)

研究者

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

Vladimir Vuksan

Professor

Unity Health Toronto

研究点 (2)

Loading locations...

相似试验