Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

Satiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515590
• Other study ID #: 1801005
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Postprandial Lipemia
• Satiety

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triacylglycerols	Fasting and postprandial blood sample analysis	6 hours
Secondary	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.	6 hours
Secondary	Gastric emptying	The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined.	6 hours
Secondary	Cholecystokinin	Fasting and postprandial blood sample analysis	6 hours
Secondary	Fatty acid composition	Fasting and postprandial blood sample analysis	6 hours
Secondary	Apolipoprotein B48	Fasting and postprandial blood sample analysis	6 hours
Secondary	Chylomicron size	Fasting and postprandial blood sample analysis	6 hours