Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starchy meal | Placebo Comparator | No Plant-based ingredient added to a starchy meal |
|
| Low dose added to starchy meal | Active Comparator | Plant-based ingredient in low dose added to starchy meal |
|
| Starchy meal and side dish | Placebo Comparator | No Plant-based ingredient added to starchy meal and side dish |
|
| Low dose added to starchy meal and side dish | Active Comparator | Plant-based ingredient in low dose added to starchy meal and side dish |
|
| Medium dose added to starchy meal and side dish | Active Comparator | Plant-based ingredient in medium dose added to starchy meal and side dish |
|
| High dose added to starchy meal and side dish |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based ingredient | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive incremental post-prandial blood glucose area unde the curve | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Positive incremental post-prandial blood glucose area under the curve | 180 minutes | |
| Post-prandial insulin response | 120 minutes | |
| Post-prandial insulin response |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | peak plasma glucose | 120 minutes |
| Cmax-baseline corrected | peak plasma glucose - baseline plasma glucose | 120 minutes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Ketul Modi, MBBS | Lambda Therapeutics Research Ltd (LTRL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lambda Therapeutics Research Ltd (LTRL) | Ahmedabad | India |
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator |
Plant-based ingredient in high dose added to starchy meal and side dish |
|
| No Plant-based ingredient | Dietary Supplement |
|
| 180 minutes |
| Assessment of gastric emptying rate | GE50% (time to empty 50% of the gastric content) will be determined with paracetamol | 10 hours |
| Tmax | peak time plasma glucose | 120 minutes |