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In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 of IQP-VV-102 | Active Comparator | Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
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| Dose 2 of IQP-VV-102 | Active Comparator | Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
|
| Placebo | Placebo Comparator | Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose 1 of IQP-VV-102 | Device | Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects. | Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in incremental PPG AUC level (mmol/L) | Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days. | 120 minutes |
| Change in total and incremental PPG AUC level (mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, PhD | Charite | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Berlin | State of Berlin | 10369 | Germany |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dose 2 of IQP-VV-102 | Device | Dose 2 (D2) group will take 4 tablets with active ingredients. |
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| Placebo | Device | Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102. |
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Measured from 0th minute, to 60th, 90th and 180th minute after intake of verum or placebo on subjects on each of the 3 visit days.
| 180 minutes |
| Changes in PPG concentration | Measured at 15, 30, 45, 60, 90, and 120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days. | 180 minutes |
| Dose response of PPG level | Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days. |
| Change in total and incremental AUC insulin level (mmol/L) | Measured from 0th minute to 120th and 180th minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days. | 180 minutes |
| Dose response of insulin level | Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days. |
| Change in total and incremental AUC triglyceride level | Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days. | 180 minutes |
| Global evaluation of tolerability both by investigator and subjects | Global scaled evaluation with "very good", "good", "moderate" and "poor" | Throughout the study (8-14 days) |
| Incidence of adverse events (Safety parameters evaluation) | Eg. Liver Function Test, Lipid parameters, Renal Function Tests. | Throughout the study period (8-14 days) |
| Reported adverse events | For any adverse event, the term of the event, intensity, duration, seriousness, frequency, outcome and assessment of causality with the investigational product will be documented in the Case Report Form (CRF) | Throughout the whole study period (8-14 days) |
| D004700 | Endocrine System Diseases |