NCT02145442

Effects of Obex in Overweight and Obese Patients

Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

* Obesity is an important and growing public health worldwide * Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer * An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients * Important adverse events have been reported with the use of antiobesity drugs. * The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT. * Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides. * Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Obex	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2014-05-23
• Last updated: 2018-05-08

Locations

1 site across 1 country: Cuba