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Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

NCT ID: NCT03515590

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Postprandial Lipemia Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Emulsion with solid droplets

Intervention Type OTHER

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 liquid droplets

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

Group Type EXPERIMENTAL

Emulsion with liquid droplets

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Amanda Wright, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Wright, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

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University of Guelph

Guelph, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31495898 (View on PubMed)

Other Identifiers

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1801005

Identifier Type: -

Identifier Source: org_study_id