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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obex | Experimental | a nutritional supplement Obex® 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. |
|
| Placebo | Placebo Comparator | Placebo 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obex | Dietary Supplement | After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight. | Change in body weight from baseline (0) after six months of treatment (i.e., weight at six month minus weight at baseline 0). Body weight measured in kilograms (k). | Six months |
| Change From Baseline in Waist Circumference at Week 24. | Change in waist circumference from baseline after six months of treatment (i.e., waist circumference at six month minus waist circumference at baseline 0). Waist measured in centimeters (cm). | Six months |
| 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 by blood analysis. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Obex® on Body Mass Index (BMI). | The BMI will be measured by Quételet index. | Six months |
| To evaluate the effect of Obex® on the waist and hip ratio. | Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roselin Valle Cabrera, BSc. | National Coordinator Center of Clinical Trials (CENCEC) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Endocrinology | Havana | La Habana | 10400 | Cuba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36804035 | Derived | Cabrera-Rode E, Cubas-Duenas I, Acosta JR, Hernandez JC, Gonzalez AIC, Calero TMG, Dominguez YA, Rodriguez JH, Rodriguez ADR, Alvarez Alvarez A, Valdes RE, Espinosa LJ, Belent OT, Benavides ZB, Estevez ES, Rodriguez YA, Del Valle Rodriguez J, Julia SM. Efficacy and safety of Obex(R) in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial. BMC Complement Med Ther. 2023 Feb 20;23(1):58. doi: 10.1186/s12906-023-03847-7. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo. |
|
| Six months |
| To evaluate the effect of Obex® on the waist and height ratio. | Waist and height ratio will be measured. | Six months |
| To evaluate the effect of Obex® on arterial blood pressures (BP). | The arterial BP will be evaluated by the doctor. | Six months |
| To evaluate the effect of Obex® on fasting insulin levels. | The insulin levels will be evaluated by blood analysis. | Six months |
| To evaluate the effect of Obex® on insulin resistance. | Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5). | Six months |
| To evaluate the effect of Obex® on insulin sensitivity. | The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated by QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0]).](streamdown:incomplete-link) | Six months |
| To evaluate the effect of Obex® on β-cell function. | Homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5). | Six months |
| To evaluate the effect of Obex® on cholesterol. | The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis. | Six months |
| To evaluate the effect of Obex® on hepatic enzymes. | The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis. | Six months |
| To evaluate the effect of Obex® on creatinine and uric acid concentrations. | The creatinine and uric acid levels will be evaluated by blood analysis. | Six months |
| To evaluate the effect of Obex® on haemoglobin levels. | The haemoglobin levels will be evaluated by blood analysis. | Six months |
| To evaluate the effect of Obex® on Conicity Index (CI) | CI will be measured by index. | Six months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |