Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

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

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.

Study Overview

• Status: Completed
• Conditions: Satiety; Postprandial Lipemia
• Intervention / Treatment: Other: Emulsion with solid droplets; Other: Emulsion with liquid droplets

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G2W1
      • University of Guelph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emulsion with solid droplets; 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; 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).
Experimental: Emulsion with liquid droplets; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Guelph
• Investigators: Principal Investigator: Amanda Wright, PhD, University of Guelph

Publications and helpful links

General Publications

• Thilakarathna SH, Hamad S, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Postprandial Plasma Triacylglycerol Responses in Healthy Men: A Randomized Double-Blind Crossover Acute Meal Study. J Nutr. 2020 Jan 1;150(1):64-72. doi: 10.1093/jn/nxz207.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 1801005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No