NCT02789683

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

April 19, 2016

Last Update Submit

November 4, 2016

Conditions

Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Insulinemic response

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

  • Triglycerides response

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

  • Non-esterified fatty acid (NEFA) response

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

  • Gastric emptying

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

  • Post-test-meal subjective appetite rating

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

Study Arms (3)

Fine emulsion

EXPERIMENTAL

Emulsion with small lipid droplet size served together with white bread

Other: Fine emulsion

Coarse emulsion

EXPERIMENTAL

Emulsion with large lipid droplet size served together with white bread

Other: Coarse emulsion

Control

EXPERIMENTAL

Non-emulsified oil and water served together with white bread

Other: Control

Interventions

Fine emulsionOTHER

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.

Fine emulsion
Coarse emulsionOTHER

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
ControlOTHER

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.

Control

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2016

First Posted

June 3, 2016

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

SG(1)