Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability

Healthy Clinical Trial

Official title:

Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990246
• Other study ID #: 19-04-003
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: August 31, 2020

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 acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially 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 four study visits, separated by at least one week. On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order. All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature. The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers. This will isolate the impacts of physical state and acid stability, and their interactions. Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage. The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of 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 four visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2020
• Est. primary completion date: March 1, 2020
• 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

• no history of gastric surgeries

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

• Healthy

Intervention

Other:
• Acid stable emulsion with solid droplets
This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)
• Acid stable emulsion with liquid droplets
This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)
• Acid unstable emulsion with solid droplets
This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)
• Acid unstable emulsion with liquid droplets
This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.5% 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	Changes in triacylglycerol blood concentrations	Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)	6 hours
Secondary	Participant visual analogue scale ratings of feelings of satiety	Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage. 0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated. The distance from the left end of the scale will be measured (cm)	6 hours
Secondary	Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations	The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)	6 hours
Secondary	Changes in fatty acid concentration of blood triacylglycerols	Analysis based on fasting and postprandial blood sample analysis (mmol/L)	6 hour
Secondary	Changes in satiety hormone blood concentrations	Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)	6 hours
Secondary	Changes in concentrations of inflammatory blood markers (ug/mL)	Analysis of blood for CD14 and LBP at fasting and postprandially	6 hours
Secondary	Rate of gastric emptying by measuring the change in the gastric antrum area	Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)	6 hours
Secondary	Changes in glucose blood concentrations	Based on determination of fasting and postprandial blood glucose (mg/dL)	6 hour