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| Name | Class |
|---|---|
| Alchemy Foodtech Pte Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibre Grains | Experimental | Fibre grains were used to partially replaced Jasmine white rice in this arm. |
|
| Jasmine white rice | Placebo Comparator | Jasmine white rice is used as a control to compare the outcome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibre Grain | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose response | A mixed 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 Fibre Grain meal and control Jasmine white rice meal. | 2 hour |
| Change in insulin response | A mixed 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 Fibre Grain meal and control Jasmine white rice meal. | 2 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ghrelin level | A mixed meal tolerance test will be done to collect blood samples for ghrelin 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 Fibre Grain meal and control Jasmine white rice meal. | 2 hour |
| Change in glucagon-like peptide 1 (GLP-1) level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mei Hui Liu | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore | Singapore | 118177 | Singapore |
The plan for individual participant data will be discussed with collaborator to decide whether to be shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 12, 2018 | Jun 10, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Fibre Grains have similar appearance to normal Jasmine white rice. It is made up of functional fibre extruded into grain-shaped food particles .
| Jasmine white rice | Dietary Supplement | 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. |
|
A mixed meal tolerance test will be done to collect blood samples for GLP-1 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 Fibre Grain meal and control Jasmine white rice meal. |
| 2 hour |
| Change in satiety rating | 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. | 2 hour |
| Change in glucose trajectories over 14 days of continous glucose monitoring | FreeStyle ® Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Singapore) was used for continuous glucose monitoring. During the study time frame, subjects were supplied with frozen meals for lunch and dinner to bring home. They were randomized to consumed 6 different combinations of food at 3 replacement levels for the rice: control (0%), 15% or 30% Fibre Grains. On day 14, subjects returned to the study facility to remove the flash glucose monitoring sensor and return the flash glucose monitoring reader. Subsequently, data was extracted from the reader by the study personnel. Glucose values were exported into Microsoft excel for visualization of the glucose trend over 14 days. | 14 days |
| D004700 | Endocrine System Diseases |