Clinical trial NCT03989908: Effects of Microfluidic Noodle on Blood Glucose Levels of Healthy Volunteers.
Official title: Insulinemic and Glycemic Evaluation of Microfluidic Food Grade Gel in Food Applications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: microfludic
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Health System
First posted: 2019-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a within-subject cross-over trial design to assess the glycemic response of microfluidic noodle consumption by human subjects as compared to mee sua (control noodle).
Primary purpose: PREVENTION

Brief summary: In this study, microfluidics was applied in the creation of low-GI food gel made from non-traditional ingredients like alginate and soy protein isolate. This method is previously tested to produce lower glycaemic response than normal noodle and pasta.

Detailed description: Research has confirmed that a food's glycemic effect cannot be accurately predicted from the type and amount of carbohydrates it contains, as the rate at which the carbohydrates is digested and released into the bloodstream is influenced by many factors such as the food's physical form, its fat, protein and fibre content, and the chemical structure of its carbohydrates. For these reasons, it is possible to produce food from the same group with different effects on blood glucose. Consumption of low GI food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. However, there are few dietary intervention studies attempting to change the GI of food by changing the staple carbohydrates. In this study, microfluidics was applied in the creation of low-GI food gel made from non-traditional ingredients like alginate and soy protein isolate. This method is previously tested to produce lower glycaemic response than normal noodle and pasta. With noodles being one of the staples to many Singaporeans, food gels formed using functional ingredients derived from food sources offer a lower GI alternative to the conventional noodle and pasta without affecting the people dietary preference.

Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Age between 21-65 years old
* Overtly healthy males or females, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
* Not on any regular medications (western / traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable.
* Have venous access sufficient to allow for blood sampling as per the protocol
* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Body mass index range of 18-25kg/m2 for male and 18-23kg/m2 for female.

Exclusion Criteria:

* History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
* Known or ongoing psychiatric disorders within 3 years
* Regularly use known drugs of abuse within 3 years
* Women who are pregnant or lactating
* Have donated blood of more than 500 mL within 4 weeks of study enrolment
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):

  * 1 unit = 12 oz or 360 mL of beer;
  * 5 oz or 150 mL of wine;
  * 1.5 oz or 45 mL of distilled spirits
* Uncontrolled hypertension (blood pressure \[BP\] \>160/100mmHg
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
* Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
* Known allergy to insulin
* History of bleeding diathesis or coagulopathy
* Any of the following laboratory values at screening:

Fasting glucose \>=126mg/dL(\>=7mmol/L) or 2 hour post-prandial glucose \>=200mg/dL (\>=11.1mmol/L)

* Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity
* Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
* Significant change in weight (+/- 5%) during the past month
* Allergy to test food

Primary outcomes:
measure: Change in glucose response
timeFrame: 2 hour
measure: Change in insulin response
timeFrame: 2 hour
Secondary outcomes:
measure: Change in ghrelin level
timeFrame: 2 hour
measure: Change in glucagon-like peptide 1 (GLP-1) level
timeFrame: 2 hour
measure: Change in satiety rating
timeFrame: 2 hour
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Mei Hui Liu
role: PRINCIPAL_INVESTIGATOR
References: