4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effects of Microfluidic Noodle on Blood Glucose Levels of Healthy Volunteers.

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Microfludic noodle Other: Control noodle Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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).
Masking: Single (Participant)
Masking Description: Participants are blinded to the noodles served.
Primary Purpose: Prevention
Official Title: Insulinemic and Glycemic Evaluation of Microfluidic Food Grade Gel in Food Applications.
Actual Study Start Date : January 13, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. Change in glucose response [ Time Frame: 2 hour ]
    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. Change in insulin response [ Time Frame: 2 hour ]
    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.


Secondary Outcome Measures :
  1. Change in ghrelin level [ Time Frame: 2 hour ]
    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. Change in glucagon-like peptide 1 (GLP-1) level [ Time Frame: 2 hour ]
    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.

  3. Change in satiety rating [ Time Frame: 2 hour ]

    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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Dimeng Yang 92717488 mdcyd@nus.edu.sg
Contact: Sean Ou mdcojls@nus.edu.sg

Locations
Layout table for location information
Singapore
National University of Singapore Recruiting
Singapore, Singapore, 118177
Contact: Dimeng Yang       mdcyd@nus.edu.sg   
Contact: Sean Ou       mdcojls@nus.edu.sg   
Principal Investigator: Chin Meng Khoo         
Principal Investigator: Mei Hui Liu         
Sponsors and Collaborators
National University, Singapore
National University Health System
Investigators
Layout table for investigator information
Principal Investigator: Mei Hui Liu National University, Singapore
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE January 13, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change in glucose response [ Time Frame: 2 hour ]
    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.
  • Change in insulin response [ Time Frame: 2 hour ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change in ghrelin level [ Time Frame: 2 hour ]
    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.
  • Change in glucagon-like peptide 1 (GLP-1) level [ Time Frame: 2 hour ]
    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.
  • Change in satiety rating [ Time Frame: 2 hour ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Microfluidic Noodle on Blood Glucose Levels of Healthy Volunteers.
Official Title  ICMJE Insulinemic and Glycemic Evaluation of Microfluidic Food Grade Gel in Food Applications.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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).
Masking: Single (Participant)
Masking Description:
Participants are blinded to the noodles served.
Primary Purpose: Prevention
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Other: Microfludic noodle
    In this intervention arm, subjects will be served with noodles made using microfludic technology.
  • Other: Control noodle
    In this intervention arm, subjects will be served with normal noodle.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Microfludic noodle
  • 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.
    Intervention: Other: Microfludic noodle
  • Placebo Comparator: Mee Sua
    Mee Sua is used as a control to compare the outcome due to its similarity in textural properties
    Intervention: Other: Control noodle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989908
Other Study ID Numbers  ICMJE 2018/01062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The plan for individual participant data will be discussed with collaborator to decide whether to be shared.
Responsible Party Mei Hui Liu, National University, Singapore
Study Sponsor  ICMJE National University, Singapore
Collaborators  ICMJE National University Health System
Investigators  ICMJE
Principal Investigator: Mei Hui Liu National University, Singapore
PRS Account National University, Singapore
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP