Obesity
Conditions
Interventions
Group A (Experimental): 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.
Group B (Control): Placeb
Dietary Supplements
Placebo
Administration, Oral
Sponsors
Catalysis, S.L. laboratory
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who fulfill the diagnosis criteria of overweight or obesity 2. Age between 20 and 65 years old. 3. Values of fasting glycemia <7.0 mmol / L and at two hours <11.1 mmol / L during PTG-O. 4. Written informed consent of participation in the study 5. BMI = 25.0 and less than 40
Exclusion criteria
Exclusion criteria: 1. Thyroid dysfunction (hypo or hyperthyroidism). 2. Type 1 or type 2 diabetes. 3. Prediabetes treated with oral agents. 4. Alterations of lipids treated with drugs. 5. Medicine consumption of or dietary supplements that influence the reduction of body weight. 6. Consumption of steroids or prolonged use of them (last 3 months). 7. Treatment with immunosuppressive drugs. 8. Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion. 9. Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia. 10. History of symptomatic hypoglycaemia 11. History of chronic debilitating diseases, anemia and collagen diseases. 11. History or existence psychological illness with eating disorders or toxicity. 12. History of alcoholism or drug dependence. 13. Inability to comply with the instructions of the investigation. 14. Severe infections at the time of inclusion. 15. Women of childbearing age who use hormonal contraceptives (oral or injectable). 16. Pregnant or breastfeeding. 17. Known sensitivity to any of the components of the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (Value in kg). Measurement time: At baseline, 3, 6, 9 and, 12 months. Waist circumference (value in cm). Measurement time: At baseline, 3, 6, 9 and, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcomes: 1. Measurements and anthropometric indexes. Measurement time: at baseline, 3, 6 and, 12 months. It will measure by: -Body Max Index-BMI (Weight/(Height*Height). The weight expressed in Kg and, the height expressed in meters) - Hip circumference (Value expressed in cm) - Waist-hip Index (Waist circumference/Hip circumference. All values are expressed in cm) - Waist- Height Index (Waist circumference/Height. All values are expressed in cm - Conicity Index (Waist circumference in cm/(0.109*square root of (weight in kg/height in cm))) 2. Glucose on an empty stomach and at two hours after an oral glucose tolerance test (Value expressed in mmol/L). Measurement time: at baseline, 6 and, 12 months. 3. Hemoglobin (Value expressed in g/L). Measurement time: at baseline, 6 and, 12 months. 4. Hemoglobina glucosilada -HbA1c (Value expressed in %). Measurement time: at baseline, 6 and, 12 months. 5. Fasting insulin (Value expressed in µU/ml). Measurement time: at baseline, 6 and, 12 months. 6. Insulin resistance indexes. - HOMA-IR will be calculated by the homeostatic model of Mathews - HOMA-ß will be determined by the homeostatic model (HOMA) of Mathew - QUICKI Index calculated as [1/[log insulin0 + log glucose0] - Bennett Index calculated as [40/insulin0] - Raynaud Index calculated as 1/(log insulin0 x log glucose0) 7. Biochemistry test (Triglycerides, Cholesterol, HDL-c, LDL-c, TGP; TGO, GGT, Uric acid, Creatinine in µmol/L). Measurement time: at baseline, 6 and, 12 months. 8. Blood Pressure (Systolic and Diastolic blood pressure expressed in mmHg).Measurement time: at baseline, 3, 6, 9 and, 12 months. Safety outcomes: 9. Adverse Events-AE. Measurement time: at baseline, 1 ½ month (6 weeks), 3 months, 4 ½ months (20 weeks), 6 months, 9 months and, 12 months. - Occurrence of some AE in the subject (Yes, No). -Type of AE (description of EA using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0) - Intensity of the AE (Light, Moderate | — |
Countries
Cuba
Contacts
Public ContactRoselin Valle Cabrera
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed