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

NCT03989908 | Completed DMC

• 1 other identifier: 2018/01062
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

microfludic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in ghrelin level

  2 hour

• Change in glucagon-like peptide 1 (GLP-1) level

  2 hour

• Change in satiety rating

  2 hour

Study Arms (3)

Co-flow alginate/SPI food gel

EXPERIMENTAL

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

Other: Microfludic noodle

Counter-flow alginate/SPI food gel

EXPERIMENTAL

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

Other: Microfludic noodle

Mee Sua

PLACEBO COMPARATOR

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

Other: Control noodle

Interventions

Microfludic noodle OTHER

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

Co-flow alginate/SPI food gel; Counter-flow alginate/SPI food gel

Control noodle OTHER

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

Mee Sua

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• unit = 12 oz or 360 mL of beer;
• oz or 150 mL of wine;
• 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:

Sponsors & Collaborators

• National University of Singapore: lead
• National University Health System: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore, 118177, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mei Hui Liu

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the noodles served.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 18, 2019
• Study Start: January 13, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 15, 2024

Record last verified: 2021-07

Locations

SG (1)