Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Other: Microfludic noodle Other: Control noodle | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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Other: Microfludic noodle
In this intervention arm, subjects will be served with noodles made using microfludic technology.
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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.
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Other: Microfludic noodle
In this intervention arm, subjects will be served with noodles made using microfludic technology.
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Placebo Comparator: Mee Sua
Mee Sua is used as a control to compare the outcome due to its similarity in textural properties
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Other: Control noodle
In this intervention arm, subjects will be served with normal noodle.
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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.
Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):
Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
Contact: Dimeng Yang | 92717488 | mdcyd@nus.edu.sg | |
Contact: Sean Ou | mdcojls@nus.edu.sg |
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 |
Principal Investigator: | Mei Hui Liu | National University, Singapore |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mei Hui Liu, National University, Singapore | ||||
Study Sponsor ICMJE | National University, Singapore | ||||
Collaborators ICMJE | National University Health System | ||||
Investigators ICMJE |
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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 |