Effects of Obex in Overweight and Obese Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Obex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight and Obese subjects with and without IFG Ability to provide informed consent Exclusion Criteria: Presence of diabetes mellitus, hepatic, renal or cardiovascular disease Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc) Sepsis or any other condition that could potentially interfere with treatment History of bariatric surgery Pregnancy or lactation Concomitant disease with reduced life expectancy Severe psychiatric conditions Anyone with chronic medical conditions requiring regular intake of any prescription medications. Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening Are actively participating in, or have participated in a formal weight loss program within the last 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obex<br>Obex®, two oral sachets daily during three months. | Dietary Supplement: Obex<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of Obex® on fasting glucose levels | The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels | Three months of treatment | 
| To determine the safety of serious supplement-related adverse events | Adverse events will be evaluated during the three months of treatment | Three months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of Obex® on fasting insulin levels | The insulin levels will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| • To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5) | The HOMA-IR will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes | The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated at baseline and at the end of treatment. QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0]) | Three months of treatment | 
| • To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5) | The HOMA-B will be evaluated at baseline and at the end of treatment | Three months of treatment | 
| • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c) | The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c) | The HbA1c will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on the body weight. | The body weight will be measured at baseline and at the end of treatment. | Three months of treatment | 
| • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI) | The BMI and CI will be measured at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on the waist and hip circumferences | Waist and Hip circumferences will be measured at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on arterial blood pressures (BP) | The arterial BP will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) | The hepatic enzymes will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on creatinine and uric acid concentrations | The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment. | Three months of treatment | 
| To evaluate the effect of Obex® on haemoglobin and serum iron levels | The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment. | Three months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired fasting glucose, Prediabetes, Obesity, Overweight, Insulin sensitivity, Weight loss, Nutritional supplement, Waist, Body composition