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

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

Sponsors

Lead Sponsor: National University, Singapore

Collaborator: National University Health System

Source National University, Singapore
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.

Overall Status Recruiting
Start Date January 13, 2019
Completion Date December 30, 2019
Primary Completion Date December 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in glucose response 2 hour
Change in insulin response 2 hour
Secondary Outcome
Measure Time Frame
Change in ghrelin level 2 hour
Change in glucagon-like peptide 1 (GLP-1) level 2 hour
Change in satiety rating 2 hour
Enrollment 15
Condition
Intervention

Intervention Type: Other

Intervention Name: Microfludic noodle

Description: In this intervention arm, subjects will be served with noodles made using microfludic technology.

Intervention Type: Other

Intervention Name: Control noodle

Description: In this intervention arm, subjects will be served with normal noodle.

Arm Group Label: Mee Sua

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mei Hui Liu Principal Investigator National University, Singapore
Overall Contact

Last Name: Dimeng Yang

Phone: 92717488

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: National University of Singapore Dimeng Yang [email protected] Chin Meng Khoo Principal Investigator Mei Hui Liu Principal Investigator
Location Countries

Singapore

Verification Date

June 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University, Singapore

Investigator Full Name: Mei Hui Liu

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Co-flow alginate/SPI food gel

Type: Experimental

Description: Direction of flow in alginate and SPI are in the same direction in the production of the microfluidic noodle.

Label: Counter-flow alginate/SPI food gel

Type: Experimental

Description: Direction of flow in alginate and SPI are in the opposite direction in the production of the microfluidic noodle.

Label: Mee Sua

Type: Placebo Comparator

Description: Mee Sua is used as a control to compare the outcome due to its similarity in textural properties

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

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

Masking: Single (Participant)

Masking Description: Participants are blinded to the noodles served.

Source: ClinicalTrials.gov