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Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

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ClinicalTrials.gov Identifier: NCT03515590
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph

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.

Condition or disease Intervention/treatment Phase
Postprandial Lipemia Satiety Other: Emulsion with solid droplets Other: Emulsion with liquid droplets Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Impact of Emulsion Droplet Physical State on Postprandial Lipemia and Satiety in Healthy Adults
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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).




Primary Outcome Measures :
  1. Triacylglycerols [ Time Frame: 6 hours ]
    Fasting and postprandial blood sample analysis


Secondary Outcome Measures :
  1. Satiety ratings [ Time Frame: 6 hours ]
    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.

  2. Gastric emptying [ Time Frame: 6 hours ]
    The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined.

  3. Cholecystokinin [ Time Frame: 6 hours ]
    Fasting and postprandial blood sample analysis

  4. Fatty acid composition [ Time Frame: 6 hours ]
    Fasting and postprandial blood sample analysis

  5. Apolipoprotein B48 [ Time Frame: 6 hours ]
    Fasting and postprandial blood sample analysis

  6. Chylomicron size [ Time Frame: 6 hours ]
    Fasting and postprandial blood sample analysis



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515590


Contacts
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Contact: Amanda Wright, PhD 519-824-4120 ext 54697 ajwright@uoguelph.ca
Contact: Surangi Thilakarathna, MSc 519-824-4120 ext 56314 sthilaka@uoguelph.ca

Locations
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Canada, Ontario
University of Guelph Recruiting
Guelph, Ontario, Canada, N1G2W1
Contact: Amanda Wright, PhD         
Sponsors and Collaborators
University of Guelph
Investigators
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Principal Investigator: Amanda Wright, PhD University of Guelph

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amanda Wright, Ph.D., Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03515590     History of Changes
Other Study ID Numbers: 1801005
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases