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

NCT ID: NCT03989908

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-13
• Study Completion Date: 2019-12-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Microfludic noodle

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Microfludic noodle

Intervention Type: OTHER

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

Mee Sua

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

Group Type: PLACEBO_COMPARATOR

Control noodle

Intervention Type: OTHER

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

Interventions

Microfludic noodle

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

Intervention Type: OTHER

Control noodle

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Health System

UNKNOWN

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Mei Hui Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei Hui Liu

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

National University of Singapore

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

2018/01062

Identifier Type: -

Identifier Source: org_study_id