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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases
• Intervention / Treatment: Other: Fine emulsion; Other: Coarse emulsion; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fine emulsion; Emulsion with small lipid droplet size served together with white bread	Other: Fine 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.
EXPERIMENTAL: Coarse emulsion; Emulsion with large lipid droplet size served together with white bread	Other: Coarse 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.
EXPERIMENTAL: Control; Non-emulsified oil and water served together with white bread	Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Blood glucose response to the test meal measured over 4 hours	4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulinemic response	Plasma insulin response to the test meal measured over 4 hours	4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Triglycerides response	Plasma triglycerides response to the test meal measured over 4 hours	4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Non-esterified fatty acid (NEFA) response	Plasma NEFA response to the test meal measured over 4 hours	4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Gastric emptying	Gastric antrum dimension measured over 2 hours	2 hours post-prandial (0, 15, 45, 90 and 120 min)
Post-test-meal subjective appetite rating	Appetite ratings will be collected after test meal consumption using a previously validated visual analog scales	4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: May 30, 2016
• First Posted (ESTIMATE): June 3, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 2015/00509