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Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose plant based ingredient | Active Comparator | Reference food with low dose of plant based ingredient |
|
| High dose plant based ingredient | Active Comparator | Reference food with high dose of plant based ingredient |
|
| Reference food format | Placebo Comparator | Reference food without plant-based ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose plant based ingredient | Dietary Supplement | Reference food with low dose of plant based ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post prandial blood glucose positive incremental area under the curve | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post prandial insulin area under the curve | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post prandial blood glucose positive incremental area under the curve | 180 and 240 minutes | |
| Post prandial insulin area under the curve | 180 and 240 minutes | |
| Glucose levels in urine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ketul Modi, MBBS | Lambda Therapeutics Research Ltd (LTRL) | Principal Investigator |
| Dr Shrikant V Deshpande | Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA | Thane | Maharashtra | India | |||
| Lambda Therapeutics Research Ttd (LTRL) |
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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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| High dose plant based ingredient | Dietary Supplement | Reference food with high dose of plant based ingredient |
|
| Reference food format | Dietary Supplement | Reference food without plant-based ingredient |
|
| 240 minutes |
| Intestinal discomfort | Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain). | 240 minutes |
| Ahemdabad |
| India |
| D004700 | Endocrine System Diseases |