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临床试验/NCT03515590
NCT03515590已完成不适用

Impact of Emulsion Droplet Physical State on Postprandial Lipemia and Satiety in Healthy Adults

University of Guelph2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Triacylglycerols

研究概览

简要总结

The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of oil-in-water emulsions in which the droplets are in either the liquid or solid (i.e. crystalline) states.

详细描述

A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend two study visits, separated by at least one week. On each study visit, fasted participants will consume either the solid or the liquid emulsion, in a randomized order. Both emulsions tested will have the exact same composition only differing in the physical state of the lipid emulsions, in order to isolate the impact of physical state, specifically, on metabolic response. Postprandial lipemia and satiety will be measured for 6 hours after consumption of the test beverage. The study meals will include crushed acetominophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the two visits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • BMI of 18 - 26 kg/m2
  • generally healthy
  • non-smoking
  • non to moderate alcohol drinkers
  • fasting plasma cholesterol level <5.2 mmol/L
  • plasma triacylglycerol level <1.7 mmol/L
  • plasma glucose level <5.6 mmol/L

排除标准

  • History of major medical conditions
  • taking prescription medications/ over the counter medications
  • taking natural health products/ dietary supplements (other than a multivitamin)
  • oral antibiotic use in the previous 3 months
  • planning to take oral antibiotics in the next 3 months
  • food allergy/anaphylactic/life-threatening allergy
  • smokers/ regular users of recreational drugs
  • elite/ training athletes
  • significant weight loss/ gain during the past 3 months
  • previous reaction/ sensitivity to acetaminophen
  • inability to avoid taking acetaminophen for 48 hours
  • sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
  • not willing to consume Sugar Twin® Sucralose or Artificial vanilla.

结局指标

主要结局

Triacylglycerols

时间窗: 6 hours

Fasting and postprandial blood sample analysis

次要结局

  • Satiety ratings(6 hours)
  • Gastric emptying(6 hours)
  • Cholecystokinin(6 hours)
  • Fatty acid composition(6 hours)
  • Apolipoprotein B48(6 hours)
  • Chylomicron size(6 hours)

研究者

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

Amanda Wright, Ph.D.

Associate Professor

University of Guelph

研究点 (2)

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