Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

Metabolic Diseases Clinical Trial

Official title:

Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789683
• Other study ID #: 2015/00509
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: November 4, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolic Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Gastric emptying	Gastric antrum dimension measured over 2 hours	2 hours post-prandial (0, 15, 45, 90 and 120 min)	No
Secondary	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)	No