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临床试验/NCT02789683
NCT02789683已完成不适用

Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

Singapore Institute of Food and Biotechnology Innovation2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Glycemic response

研究概览

简要总结

The aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.

详细描述

This study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed together with bread. All participants will be randomly allocated to the three test meals. Fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in Singapore.

During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. Gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. Each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy Chinese male subjects aged between 21 and 50 years
  • Body mass index between 20.0 to 24.9 kg/m2
  • Normal blood pressure (<140/90 mmHg)
  • Fasting blood glucose <6.0 mmol/L

排除标准

  • People with major chronic disease such as heart disease, cancer or diabetes mellitus
  • People with family history of diabetes or familial cholesterolaemic
  • People with history of liver or renal problems
  • People who have intolerances or allergies to test products
  • Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
  • People with a major medical or surgical event requiring hospitalization within the preceding three months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients

结局指标

主要结局

Glycemic response

时间窗: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

Blood glucose response to the test meal measured over 4 hours

次要结局

  • Gastric emptying(2 hours post-prandial (0, 15, 45, 90 and 120 min))
  • Insulinemic response(4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min))
  • Triglycerides response(4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min))
  • Non-esterified fatty acid (NEFA) response(4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min))
  • Post-test-meal subjective appetite rating(4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min))

研究者

发起方
Singapore Institute of Food and Biotechnology Innovation
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

JeyaKumar Henry

Principal Investigator

Singapore Institute of Food and Biotechnology Innovation

研究点 (2)

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