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| Name | Class |
|---|---|
| Fuji Oil Co. Ltd. | UNKNOWN |
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This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on glucose parameters, triglycerides and body weight as compared to a placebo. Half of the subjects will be administered Glucodia™, while the other half will receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucodia™ | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucodia™ | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo | Assessed by the change in the area under the curve in glucose response | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo | Assessed by the change in the area under the curve in insulin response | Baseline and week 8 |
| Change in fasting glucose in subjects taking Glucodia™ versus Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Vital Signs in subjects taking Glucodia™ versus Placebo | Blood Pressure and Heart Rate | Screening, Baseline, week 4, week 8 |
| Changes in Blood Hematology and Clinical Chemistry in subjects taking Glucodia™ versus Placebo |
Inclusion Criteria:
OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Double-barrier method (condoms with spermicide or diaphragm with spermacide), Non-hormonal intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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|
| Baseline, week 4 and week 8 |
| Change in fasting insulin in subjects taking Glucodia™ versus Placebo | Baseline, week 4 and week 8 |
| Change in HOMA-IR in subjects taking Glucodia™ versus Placebo | Baseline, week 4 and week 8 |
| Change in adiponectin levels in subjects taking Glucodia™ versus Placebo | Baseline, week 4 and week 8 |
| Change in lipid panel levels in subjects taking Glucodia™ versus Placebo | Lipid panel includes total cholesterol, triglycerides, HDL, LDL, free fatty acids and non-esterified fatty acids | Baseline, week 4 and week 8 |
| Change in body composition in subjects taking Glucodia™ versus Placebo | Assessed via DXA scan | Baseline, week 4 and week 8 |
| Change in body composition in subjects taking Glucodia™ versus Placebo | Assessed via circumference measurements of the arm, thigh, hip and waist and the hip to waist ratio | Baseline, week 4 and week 8 |
| Change in body weight in subjects taking Glucodia™ versus Placebo | Baseline, week 4 and week 8 |
| Change in appetite in subjects taking Glucodia™ versus Placebo | Assessed using a Satiety VAS scale questionnaire | Baseline, week 4 and week 8 |
CBC, electrolytes, creatinine, AST, ALT, GGT, bilirubin, HbA1c, BUN, total protein, albumin, globulin and calcium
| Screening, Baseline, week 4 and week 8 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |