Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
- Conditions
- Healthy
- Interventions
- Other: Acid stable emulsion with solid dropletsOther: Acid stable emulsion with liquid dropletsOther: Acid unstable emulsion with solid dropletsOther: Acid unstable emulsion with liquid droplets
- Registration Number
- NCT03990246
- Lead Sponsor
- University of Guelph
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acid stable emulsion with solid droplets Acid stable emulsion with solid droplets Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. Acid stable emulsion with liquid droplets Acid stable emulsion with liquid droplets Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. Acid unstable emulsion with solid droplets Acid unstable emulsion with solid droplets Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen. Acid unstable emulsion with liquid droplets Acid unstable emulsion with liquid droplets Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
- Primary Outcome Measures
Name Time Method Changes in triacylglycerol blood concentrations 6 hours Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
- Secondary Outcome Measures
Name Time Method Changes in satiety hormone blood concentrations 6 hours Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)
Participant visual analogue scale ratings of feelings of satiety 6 hours 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)
Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations 6 hours The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)
Changes in fatty acid concentration of blood triacylglycerols 6 hour Analysis based on fasting and postprandial blood sample analysis (mmol/L)
Changes in concentrations of inflammatory blood markers (ug/mL) 6 hours Analysis of blood for CD14 and LBP at fasting and postprandially
Rate of gastric emptying by measuring the change in the gastric antrum area 6 hours Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm\*cm)
Changes in glucose blood concentrations 6 hour Based on determination of fasting and postprandial blood glucose (mg/dL)
Trial Locations
- Locations (1)
University of Guelph
🇨🇦Guelph, Ontario, Canada