Efficacy and safety of the Obex® nutritional supplement in overweight and obese subjects. Phase III

Catalysis, S.L. laboratory0 个研究点目标入组 160 人开始时间: 2018年4月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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

•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

发起方

Catalysis, S.L. laboratory