Overview

This trial has been completed.

Condition metabolic diseases
Treatments fine emulsion, coarse emulsion, control
Sponsor Clinical Nutrition Research Centre, Singapore
Start date July 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02789683, 2015/00509

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Emulsion with small lipid droplet size served together with white bread
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)
Emulsion with large lipid droplet size served together with white bread
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)
Non-emulsified oil and water served together with white bread
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Insulinemic response
time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Triglycerides response
time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
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)
Gastric emptying
time frame: 2 hours post-prandial (0, 15, 45, 90 and 120 min)
Post-test-meal subjective appetite rating
time frame: 4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)

Eligibility Criteria

Male participants from 21 years up to 50 years old.

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

Additional Information

Official title Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Clinical Nutrition Research Centre, Singapore.