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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obex | Experimental | Obex®, two oral sachets daily during three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obex | Dietary Supplement | Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Obex® on fasting glucose levels | The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels | Three months of treatment |
| To determine the safety of serious supplement-related adverse events | Adverse events will be evaluated during the three months of treatment | Three months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Obex® on fasting insulin levels | The insulin levels will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| • To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Cabrera, M.D., Ph.D. | National Institute of Endocrinology, Havana, Cuba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Endocrinology | Plaza de la Revolución | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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The HOMA-IR will be evaluated at baseline and at the end of treatment. |
| Three months of treatment |
| To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes | The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated at baseline and at the end of treatment. QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0])](streamdown:incomplete-link) | Three months of treatment |
| • To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5) | The HOMA-B will be evaluated at baseline and at the end of treatment | Three months of treatment |
| • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c) | The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c) | The HbA1c will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on the body weight. | The body weight will be measured at baseline and at the end of treatment. | Three months of treatment |
| • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI) | The BMI and CI will be measured at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on the waist and hip circumferences | Waist and Hip circumferences will be measured at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on arterial blood pressures (BP) | The arterial BP will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) | The hepatic enzymes will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on creatinine and uric acid concentrations | The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| To evaluate the effect of Obex® on haemoglobin and serum iron levels | The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment. | Three months of treatment |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D001836 | Body Weight Changes |