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Completed

NCT Number: NCT02789683

Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

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.

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Key information

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Fine emulsion

Other

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.

Coarse emulsion

Other

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.

Control

Other

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.

Primary outcomes

  1. Glycemic response

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

    Blood glucose response to the test meal measured over 4 hours

Secondary outcomes

  1. Insulinemic response

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

    Plasma insulin response to the test meal measured over 4 hours

  2. Triglycerides response

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

    Plasma triglycerides response to the test meal measured over 4 hours

  3. Non-esterified fatty acid (NEFA) response

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

    Plasma NEFA response to the test meal measured over 4 hours

  4. Gastric emptying

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

    Gastric antrum dimension measured over 2 hours

  5. Post-test-meal subjective appetite rating

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

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

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2016
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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