Effects of Microfluidic Noodle on Blood Glucose Levels of Healthy Volunteers.

Insulinemic and Glycemic Evaluation of Microfluidic Food Grade Gel in Food Applications.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Microfludic noodle; Other: Control noodle

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 118177
    • National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Co-flow alginate/SPI food gel; Direction of flow in alginate and SPI are in the same direction in the production of the microfluidic noodle.	Other: Microfludic noodle; In this intervention arm, subjects will be served with noodles made using microfludic technology.
Experimental: Counter-flow alginate/SPI food gel; Direction of flow in alginate and SPI are in the opposite direction in the production of the microfluidic noodle.	Other: Microfludic noodle; In this intervention arm, subjects will be served with noodles made using microfludic technology.
Placebo Comparator: Mee Sua; Mee Sua is used as a control to compare the outcome due to its similarity in textural properties	Other: Control noodle; In this intervention arm, subjects will be served with normal noodle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose response	A meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in glucose response will be measured by comparing incremental area under the curve (iAUC) after ingestion of Microfluidic noodle meal and control Mee sua meal.	2 hour
Change in insulin response	A meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in insulin response will be measured by comparing incremental area under the curve (iAUC) after ingestion of Microfluidic noodle meal and control Mee sua meal.	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ghrelin level	A meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in ghrelin level will be measured by comparing AUC after ingestion of Microfluidic meal and control Mee sua meal.	2 hour
Change in glucagon-like peptide 1 (GLP-1) level	A meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in GLP-1 level will be measured by comparing AUC after ingestion of Microfluidic meal and control Mee sua meal.	2 hour
Change in satiety rating	A visual analogue scale (VAS) will be presented to the participants at 0, min, 30 min, 60 min , 90 min and 120 min, to indicate how they feel in response to 4 given statements by marking an "X" on a 100-mm line. At time T=12 min, palatability of the treatment was assessed by five characteristics, from bad (0 mm) to good (100 mm). These characteristics were visual appeal, smell, taste, texture, and overall pleasantness of the meal given. Scores were determined by measuring the distance (in mm) from the let starting point of the line to the intersection of the "X". Subjects did not discuss their ratings.The primary outcome was area under the curve (AUC) for responses on the VAS calculated using the trapezoidal rule.	2 hour

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: National University Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: microfludic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2018/01062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The plan for individual participant data will be discussed with collaborator to decide whether to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No