Clinical trial NCT02789683: Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
Official title: Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2016-06-03
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic response
timeFrame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Secondary outcomes:
measure: Insulinemic response
timeFrame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
measure: Triglycerides response
timeFrame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
measure: Non-esterified fatty acid (NEFA) response
timeFrame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
measure: Gastric emptying
timeFrame: 2 hours post-prandial (0, 15, 45, 90 and 120 min)
measure: Post-test-meal subjective appetite rating
timeFrame: 4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: