Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Dietary Supplement: Fibre Grain Dietary Supplement: Jasmine white rice | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 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 fibre enriched rice consumer by human subjects as compared to normal non-enriched rice in a mixed meal setting. |
Masking: | Single (Participant) |
Masking Description: | Fibre Grains have similar appearance to normal Jasmine white rice. It is made up of functional fibre extruded into grain-shaped food particles . |
Primary Purpose: | Prevention |
Official Title: | Effects of Fixed Meals With Special Formulated Rice on Blood Glucose Levels of Healthy Volunteers. |
Actual Study Start Date : | July 3, 2018 |
Estimated Primary Completion Date : | December 30, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Experimental: Fibre Grains
Fibre grains were used to partially replaced Jasmine white rice in this arm.
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Dietary Supplement: Fibre Grain
Healthy subjects will be provided with 30% Fibre Grain in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.
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Placebo Comparator: Jasmine white rice
Jasmine white rice is used as a control to compare the outcome.
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Dietary Supplement: Jasmine white rice
Healthy subjects will be provided with Jasmine white rice in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.
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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=15 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:
Singapore | |
National University of Singapore | |
Singapore, Singapore, 118177 |
Principal Investigator: | Mei Hui Liu | National University, Singapore |
Tracking Information | |||||
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First Submitted Date ICMJE | June 10, 2019 | ||||
First Posted Date ICMJE | June 13, 2019 | ||||
Last Update Posted Date | February 26, 2020 | ||||
Actual Study Start Date ICMJE | July 3, 2018 | ||||
Estimated Primary Completion Date | December 30, 2020 (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 | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of Fixed Meals With Special Formulated Rice on Blood Glucose Levels of Healthy Volunteers. | ||||
Official Title ICMJE | Effects of Fixed Meals With Special Formulated Rice on Blood Glucose Levels of Healthy Volunteers. | ||||
Brief Summary | The aim of the study is to compare Diabetec® Fibre Grains (FIbre Grains) in a mixed meal setting with Jasmine rice. This is to see whether partial replacement of white rice with Fibre Grains can reduce postprandial blood glucose control. | ||||
Detailed Description | Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally accepted as the cornerstone for the treatment of people with type 2 diabetes. 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, formulated rice with special fibre enrichment, Fibre Grains, was used to replace rice as the staple carbohydrates in one's diet. This fibre enriched rice has been previously tested to have a lower GI than normal rice while still able to preserve all the sensory characteristics of normal rice. With rice being a staple to Asians, this specially formulated fibre enriched rice offers a lower GI alternative to the conventional rice 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 fibre enriched rice consumer by human subjects as compared to normal non-enriched rice in a mixed meal setting. Masking: Single (Participant)Masking Description: Fibre Grains have similar appearance to normal Jasmine white rice. It is made up of functional fibre extruded into grain-shaped food particles . 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 | Active, not recruiting | ||||
Actual Enrollment ICMJE |
22 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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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 | NCT03985566 | ||||
Other Study ID Numbers ICMJE | 2017/01126 | ||||
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 | Alchemy Foodtech Pte Ltd | ||||
Investigators ICMJE |
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PRS Account | National University, Singapore | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |