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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acid stable emulsion with solid droplets | Experimental | Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. |
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| Acid stable emulsion with liquid droplets | Experimental | Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. |
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| Acid unstable emulsion with solid droplets | Experimental | Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. |
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| Acid unstable emulsion with liquid droplets | Experimental | Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acid stable emulsion with solid droplets | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in triacylglycerol blood concentrations | Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L) | 6 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guelph | Guelph | Ontario | N1G 2W1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41834246 | Derived | Rogers MA, Wright AJ. The Role of Food Structure on Fatty Acid Bioaccessibility: A Decade of TIM-1 Simulated Digestion Studies in Review. Mol Nutr Food Res. 2026 Mar;70(6):e70434. doi: 10.1002/mnfr.70434. | |
| 33963742 | Derived | Hamad S, Tari NR, Mathiyalagan G, Wright AJ. Emulsion acid colloidal stability and droplet crystallinity modulate postprandial gastric emptying and short-term satiety: a randomized, double-blinded, crossover, controlled trial in healthy adult males. Am J Clin Nutr. 2021 Sep 1;114(3):997-1011. doi: 10.1093/ajcn/nqab116. |
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|
| Acid stable emulsion with liquid droplets | Other | 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) |
|
| Acid unstable emulsion with solid droplets | Other | 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) |
|
| Acid unstable emulsion with liquid droplets | Other | 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) |
|
| 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 |
| 32556204 | Derived | Hamad S, Thilakarathna SH, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study. J Nutr. 2020 Sep 1;150(9):2295-2304. doi: 10.1093/jn/nxaa164. |