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Completed

NCT Number: NCT03515590

Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph

Guelph, Ontario, N1G2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emulsion with solid droplets

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

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).

Primary outcomes

  1. Triacylglycerols

    Time frame: 6 hours

    Fasting and postprandial blood sample analysis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study title

Impact of Emulsion Droplet Physical State on Postprandial Lipemia and Satiety in Healthy Adults

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 3, 2018
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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