CompletedInterventionalPhase 4Updated Jun 23, 2021
Evaluation of Obex® in Overweight and Obesity | NCT03541005 | Trialant
CompletedInterventionalPhase 3Updated Oct 21, 2021
Evaluation of Obex® in Overweight and Obesity
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
ClinicalTrials.gov ID
NCT03541005
Lead Sponsor
Catalysis SLINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
160Actual
Last Update Posted
Oct 21, 2021Actual
Start Date
Oct 1, 2018Actual
Primary Completion Date
Sep 1, 2019Actual
Completion Date
Jul 3, 2021Actual
Official Title
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
Brief Summary
Obesity 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.
Overweight and Obesity
Obex
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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