Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postprandial Lipemia, Satiety

Intervention / Treatment
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* Other: Emulsion with solid droplets
* Other: Emulsion with liquid droplets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emulsion with solid droplets<br>Emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Emulsion with solid droplets<br>* This will be a 500 mL beverage emulsion in which the droplets are crystalline. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).<br>|
| Experimental: Emulsion with liquid droplets<br>Emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Emulsion with liquid droplets<br>* This will be a 500 mL beverage emulsion in which the droplets are liquid. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triacylglycerols | Fasting and postprandial blood sample analysis | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety ratings | Visual analogue scale ratings of feelings of hunger, fullness, appetite, fatigue, after consuming the emulsion beverage. 0: not hungry, empty, no appetite and no fatigue and 10: very hungry, very full, can eat a lot and very fatigued. The distance from the left end of the scale will be measured. | 6 hours | 
| Gastric emptying | The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined. | 6 hours | 
| Cholecystokinin | Fasting and postprandial blood sample analysis | 6 hours | 
| Fatty acid composition | Fasting and postprandial blood sample analysis | 6 hours | 
| Apolipoprotein B48 | Fasting and postprandial blood sample analysis | 6 hours | 
| Chylomicron size | Fasting and postprandial blood sample analysis | 6 hours |