Title
Evaluation of Obex® in Overweight and Obesity
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
Phase
Phase 3Lead Sponsor
Catalysis SLStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Overweight and ObesityIntervention/Treatment
Obex ...Study Participants
160Obesity is an important and growing worldwide
Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
Diverse adverse events have been reported with the use of antiobesity drugs.
Several articles describe the beneficial effect of several specific components of the Obex® supplement on weight loss, in the reduction of waist circumference, suppression of appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β cells function.
Therefore, the administration of Obex in overweight and obese patients could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
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 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.
Inclusion Criteria: Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 and less than 40). Age between 20 and 65 years old. Values of fasting glucose < 7.0 mmol / L and at two hours < 11.1 mmol / L during Glucose Tolerance Test (OGTT). Written informed consent of participation in the study. Exclusion Criteria: Thyroid dysfunction (hypo or hyperthyroidism). Type 1 or type 2 diabetes. Prediabetes treated with oral agents. Alterations of lipids treated with drugs. Medicine consumption of or dietary supplements that influence the reduction of body weight. Consumption of steroids or prolonged use of them (last 3 months). Treatment with immunosuppressive drugs. Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion. Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia. History of symptomatic hypoglycaemia. History of chronic debilitating diseases, anemia and collagen diseases. History or existence psychological illness with eating disorders or toxicity. History of alcoholism or drug dependence. Inability to comply with the instructions of the investigation. Severe infections at the time of inclusion. Women of childbearing age who use hormonal contraceptives (oral or injectable). Pregnant or breastfeeding. Known sensitivity to any of the components of the formulation Gynoid fat distribution.
