Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2019
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedOctober 27, 2020
October 1, 2020
9 months
June 12, 2019
October 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in triacylglycerol blood concentrations
Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
6 hours
Secondary Outcomes (7)
Participant visual analogue scale ratings of feelings of satiety
6 hours
Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations
6 hours
Changes in fatty acid concentration of blood triacylglycerols
6 hour
Changes in satiety hormone blood concentrations
6 hours
Changes in concentrations of inflammatory blood markers (ug/mL)
6 hours
- +2 more secondary outcomes
Study Arms (4)
Acid stable emulsion with solid droplets
EXPERIMENTALAcid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Acid stable emulsion with liquid droplets
EXPERIMENTALAcid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Acid unstable emulsion with solid droplets
EXPERIMENTALAcid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Acid unstable emulsion with liquid droplets
EXPERIMENTALAcid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
Interventions
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)
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)
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Guelph
Guelph, Ontario, N1G 2W1, Canada
Related Publications (2)
Hamad S, Tari NR, Mathiyalagan G, Wright AJ. Emulsion acid colloidal stability and droplet crystallinity modulate postprandial gastric emptying and short-term satiety: a randomized, double-blinded, crossover, controlled trial in healthy adult males. Am J Clin Nutr. 2021 Sep 1;114(3):997-1011. doi: 10.1093/ajcn/nqab116.
PMID: 33963742DERIVEDHamad S, Thilakarathna SH, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study. J Nutr. 2020 Sep 1;150(9):2295-2304. doi: 10.1093/jn/nxaa164.
PMID: 32556204DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 18, 2019
Study Start
June 12, 2019
Primary Completion
March 1, 2020
Study Completion
August 31, 2020
Last Updated
October 27, 2020
Record last verified: 2020-10