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

University of Guelph

Status: Completed

Conditions: Healthy

Treatments: Other: Acid unstable emulsion with liquid droplets; Other: Acid stable emulsion with liquid droplets; Other: Acid stable emulsion with solid droplets; Other: Acid unstable emulsion with solid droplets

Study type: Interventional

Funder types: Other

Identifiers

NCT03990246

19-04-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 4 patient groups

Acid stable emulsion with solid droplets

Experimental group

Description:

Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.

Treatment:

Other: Acid stable emulsion with solid droplets

Acid stable emulsion with liquid droplets

Experimental group

Description:

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

Treatment:

Other: Acid stable emulsion with liquid droplets

Acid unstable emulsion with solid droplets

Experimental group

Description:

Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.

Treatment:

Other: Acid unstable emulsion with solid droplets

Acid unstable emulsion with liquid droplets

Experimental group

Description:

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

Treatment:

Other: Acid unstable emulsion with liquid droplets