NCT03515590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

April 11, 2018

Last Update Submit

October 26, 2020

Conditions

Postprandial LipemiaSatiety

Outcome Measures

Primary Outcomes (1)

  • Triacylglycerols

    Fasting and postprandial blood sample analysis

    6 hours

Secondary Outcomes (6)

  • Satiety ratings

    6 hours

  • Gastric emptying

    6 hours

  • Cholecystokinin

    6 hours

  • Fatty acid composition

    6 hours

  • Apolipoprotein B48

    6 hours

  • +1 more secondary outcomes

Study Arms (2)

Emulsion with solid droplets

EXPERIMENTAL

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

Emulsion with liquid droplets

EXPERIMENTAL

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

Interventions

Emulsion with solid dropletsOTHER

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).

Emulsion with solid droplets
Emulsion with liquid dropletsOTHER

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).

Emulsion with liquid droplets

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31495898DERIVED

MeSH Terms

Interventions

Emulsions

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Amanda Wright, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 3, 2018

Study Start

July 2, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

CA(1)