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The goal of this randomized, double-blind, cross-over inverventional study is to evaluate the efficacy of white kidney bean on OGTT (oral glucose tolerance test). About 34 eligible participants will be randomized in two groups of the same size to take the assigned interventions at one study site in Shanghai, two visits will be required. The first group of participants will take Wonderlab product first and then placebo product after 72 hours of washout period, while the other group of of participants will take placebo product first and then Wonderlab product after 72 hours of washout period. For each visit, the finger blood will be sampled and the relevent data such as blood glucose will be captured based on OGTT procedures, and recorded into clinical data management system for statistical analysis.
Researchers will compare the two groups to see if there is significant change of blood glucose by using products containing ingredient of white kidney beans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wonderlab Product plus Placebo | Active Comparator | Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean. Placebo: 4g/tablet, per serving 750mg Maltodextrin |
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| Placebo plus Wonderlab Product | Active Comparator | Placebo: 4g/tablet, per serving 750mg Maltodextrin Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1 Wonderlab Product | Dietary Supplement | Chew two tablets of Wonderlab Product for phase 1 (day 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention | The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours. | At the end of Phase 1 and Phase 2 (each phase is 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention | The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours. |
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Inclusion Criteria:
Healthy adults aged 25-45 years, with a male to female ratio of more than 40% and BMI 24.
35 subjects enrolled and 30 subjects completed the study;
There is no history of diabetes and other metabolic syndrome, digestive diseases, endocrine disorder and mental diseases;
No history of food allergy and intolerance;
No nutritional supplements that affect glucose tolerance, oral contraceptives, acetylsalicylic acid, steroids, protease inhibitors, and antipsychotic drugs in the past 3 months;
Able to tolerate at least 10 hours of fasting;
Willing to refrain from participating in other interventional clinical studies during the trial period;
Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
Willing to obey all test requirements and procedures;
Informed consent signed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Zhang, MD | SPRIM Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPRIM Central Lab | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Phase 1 Placebo | Dietary Supplement | Washout 72 hours and chew two tablets of placebo for phase 2 (day 4). |
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| Phase 2 Placebo | Dietary Supplement | Chew two tablets of placebo for phase 1 (day 1) |
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| Phase 2 Wonderlab Product | Dietary Supplement | Washout 72 hours and chew two tablets of Wonderlab Product for phase 2 (day 4). |
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| At the end of Phase 1 and Phase 2 (each phase is 1 day) |