Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males
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
- Changes in triacylglycerol blood concentrations
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 acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially 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 four study visits, separated by at least one week. On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order. All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature. The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers. This will isolate the impacts of physical state and acid stability, and their interactions. Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage. The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of 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 four visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
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
- •no history of gastric surgeries
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
Changes in triacylglycerol blood concentrations
时间窗: 6 hours
Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
次要结局
- Participant visual analogue scale ratings of feelings of satiety(6 hours)
- Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations(6 hours)
- Changes in fatty acid concentration of blood triacylglycerols(6 hour)
- Changes in satiety hormone blood concentrations(6 hours)
- Changes in concentrations of inflammatory blood markers (ug/mL)(6 hours)
- Rate of gastric emptying by measuring the change in the gastric antrum area(6 hours)
- Changes in glucose blood concentrations(6 hour)
研究者
Amanda Wright, Ph.D.
Associate Professor
University of Guelph