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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

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.

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

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 2W1
      • 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
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Acid stable emulsion with solid droplets; 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)
Experimental: 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.	Other: Acid stable emulsion with liquid droplets; 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)
Experimental: 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.	Other: Acid unstable emulsion with solid droplets; 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)
Experimental: 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.	Other: Acid unstable emulsion with liquid droplets; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Guelph

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

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

• Other Study ID Numbers: 19-04-003

Drug and device information, study documents

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