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Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

Primary Purpose

Postprandial Lipemia, Satiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Emulsion with solid droplets
Emulsion with liquid droplets
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Lipemia

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Guelph

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Emulsion with solid droplets

Emulsion with liquid droplets

Arm Description

Emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.

Emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.

Outcomes

Primary Outcome Measures

Triacylglycerols
Fasting and postprandial blood sample analysis

Secondary Outcome Measures

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.
Gastric emptying
The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined.
Cholecystokinin
Fasting and postprandial blood sample analysis
Fatty acid composition
Fasting and postprandial blood sample analysis
Apolipoprotein B48
Fasting and postprandial blood sample analysis
Chylomicron size
Fasting and postprandial blood sample analysis

Full Information

First Posted
April 11, 2018
Last Updated
October 26, 2020
Sponsor
University of Guelph
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1. Study Identification

Unique Protocol Identification Number
NCT03515590
Brief Title
Emulsion Droplet Physical State on Postprandial Lipemia and Satiety
Official Title
Impact of Emulsion Droplet Physical State on Postprandial Lipemia and Satiety in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipemia, Satiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emulsion with solid droplets
Arm Type
Experimental
Arm Description
Emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Arm Title
Emulsion with liquid droplets
Arm Type
Experimental
Arm Description
Emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Intervention Type
Other
Intervention Name(s)
Emulsion with solid droplets
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Emulsion with liquid droplets
Intervention Description
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).
Primary Outcome Measure Information:
Title
Triacylglycerols
Description
Fasting and postprandial blood sample analysis
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Satiety ratings
Description
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.
Time Frame
6 hours
Title
Gastric emptying
Description
The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined.
Time Frame
6 hours
Title
Cholecystokinin
Description
Fasting and postprandial blood sample analysis
Time Frame
6 hours
Title
Fatty acid composition
Description
Fasting and postprandial blood sample analysis
Time Frame
6 hours
Title
Apolipoprotein B48
Description
Fasting and postprandial blood sample analysis
Time Frame
6 hours
Title
Chylomicron size
Description
Fasting and postprandial blood sample analysis
Time Frame
6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Wright, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31495898
Citation
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.
Results Reference
derived

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Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

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