* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
National Institute of Endocrinology
Plaza de la Revolución, La Habana, Cuba
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
Time frame: 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
Time frame: Three months of treatment
To evaluate the effect of Obex® on fasting insulin levels
The insulin levels will be evaluated at baseline and at the end of treatment.
Time frame: 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.
Time frame: 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) = \[40/I0\])
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three months of treatment
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