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CompletedNCT02789683Updated Nov 6, 2016

Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

An interventional study of Fine emulsion and Coarse emulsion in Metabolic Diseases, sponsored by Singapore Institute of Food and Biotechnology Innovation. Completed at 1 site in Singapore. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by Singapore Institute of Food and Biotechnology Innovation · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study summary

The aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.

Read the detailed description

This study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed together with bread. All participants will be randomly allocated to the three test meals. Fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in Singapore.

During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. Gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. Each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.

02

Conditions studied

  • Metabolic Diseases

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03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 20 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation is the lead sponsor of 69 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Chinese male subjects aged between 21 and 50 years
  • Body mass index between 20.0 to 24.9 kg/m2
  • Normal blood pressure (\<140/90 mmHg)
  • Fasting blood glucose \<6.0 mmol/L

Exclusion criteria

Exclusion Criteria:

  • People with major chronic disease such as heart disease, cancer or diabetes mellitus
  • People with family history of diabetes or familial cholesterolaemic
  • People with history of liver or renal problems
  • People who have intolerances or allergies to test products
  • Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
  • People with a major medical or surgical event requiring hospitalization within the preceding three months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Fine emulsion

    Emulsion with small lipid droplet size served together with white bread

    Other: Fine emulsion

  • Experimental
    Coarse emulsion

    Emulsion with large lipid droplet size served together with white bread

    Other: Coarse emulsion

  • Experimental
    Control

    Non-emulsified oil and water served together with white bread

    Other: Control

Interventions

  • OtherFine emulsion

    Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.

  • OtherCoarse emulsion

    Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.

  • OtherControl

    Beverage is made up of distilled water and olive oil. Beverage will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.

06

What researchers measure

Primary outcomes

  1. Glycemic response

    Blood glucose response to the test meal measured over 4 hours

    Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

Secondary outcomes

  1. Insulinemic response

    Plasma insulin response to the test meal measured over 4 hours

    Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

  2. Triglycerides response

    Plasma triglycerides response to the test meal measured over 4 hours

    Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

  3. Non-esterified fatty acid (NEFA) response

    Plasma NEFA response to the test meal measured over 4 hours

    Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

  4. Gastric emptying

    Gastric antrum dimension measured over 2 hours

    Time frame: 2 hours post-prandial (0, 15, 45, 90 and 120 min)

  5. Post-test-meal subjective appetite rating

    Appetite ratings will be collected after test meal consumption using a previously validated visual analog scales

    Time frame: 4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

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Study locations

1 site
  • Clinical Nutrition Research Centre
    Singapore, 117599, Singapore
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02789683
Lead sponsor
Singapore Institute of Food and Biotechnology Innovation
Responsible party
JeyaKumar Henry (Principal Investigator, Singapore Institute of Food and Biotechnology Innovation) — Principal investigator
First posted
Jun 3, 2016
Start date
Jul 2015
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Nov 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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