Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability

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 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.

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 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.

Official Title
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Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males

Conditions
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Healthy

Intervention / Treatment
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* Other: Acid stable emulsion with solid droplets
* Other: Acid stable emulsion with liquid droplets
* Other: Acid unstable emulsion with solid droplets
* Other: Acid unstable 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 no history of gastric surgeries 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acid stable emulsion with solid droplets<br>Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Acid stable emulsion with solid droplets<br>* This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)<br>|
| Experimental: Acid stable emulsion with liquid droplets<br>Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Acid stable emulsion with liquid droplets<br>* This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)<br>|
| Experimental: Acid unstable emulsion with solid droplets<br>Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Acid unstable emulsion with solid droplets<br>* This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)<br>|
| Experimental: Acid unstable emulsion with liquid droplets<br>Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. | Other: Acid unstable emulsion with liquid droplets<br>* This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.5% 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 |
| --- | --- | --- |
| Changes in triacylglycerol blood concentrations | Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant visual analogue scale ratings of feelings of satiety | Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage. 0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated. The distance from the left end of the scale will be measured (cm) | 6 hours | 
| Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations | The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L) | 6 hours | 
| Changes in fatty acid concentration of blood triacylglycerols | Analysis based on fasting and postprandial blood sample analysis (mmol/L) | 6 hour | 
| Changes in satiety hormone blood concentrations | Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL) | 6 hours | 
| Changes in concentrations of inflammatory blood markers (ug/mL) | Analysis of blood for CD14 and LBP at fasting and postprandially | 6 hours | 
| Rate of gastric emptying by measuring the change in the gastric antrum area | Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm) | 6 hours | 
| Changes in glucose blood concentrations | Based on determination of fasting and postprandial blood glucose (mg/dL) | 6 hour |