Overweight and Obesity
Conditions
Keywords
Overweight, Obesity, Nutritional supplement, Weight loss, waist
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.
Interventions
DIETARY_SUPPLEMENTObex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
DIETARY_SUPPLEMENTPlacebo
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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 * Gynoid fat distribution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight. | Six months | Change in body weight from baseline (0) after six months of treatment (i.e., weight at six month minus weight at baseline 0). Body weight measured in kilograms (k). |
| Change From Baseline in Waist Circumference at Week 24. | Six months | Change in waist circumference from baseline after six months of treatment (i.e., waist circumference at six month minus waist circumference at baseline 0). Waist measured in centimeters (cm). |
| To evaluate the effect of Obex® on fasting glucose levels. | Six months | The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of Obex® on arterial blood pressures (BP). | Six months | The arterial BP will be evaluated by the doctor. |
| To evaluate the effect of Obex® on fasting insulin levels. | Six months | The insulin levels will be evaluated by blood analysis. |
| To evaluate the effect of Obex® on insulin resistance. | Six months | Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5). |
| To evaluate the effect of Obex® on insulin sensitivity. | Six months | The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated by QUICKI = \[1/\[log I0 + log G0\], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = \[40/I0\]). |
| To evaluate the effect of Obex® on β-cell function. | Six months | Homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5). |
| To evaluate the effect of Obex® on Body Mass Index (BMI). | Six months | The BMI will be measured by Quételet index. |
| To evaluate the effect of Obex® on hepatic enzymes. | Six months | The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis. |
| To evaluate the effect of Obex® on creatinine and uric acid concentrations. | Six months | The creatinine and uric acid levels will be evaluated by blood analysis. |
| To evaluate the effect of Obex® on haemoglobin levels. | Six months | The haemoglobin levels will be evaluated by blood analysis. |
| To evaluate the effect of Obex® on Conicity Index (CI) | Six months | CI will be measured by index. |
| To evaluate the effect of Obex® on cholesterol. | Six months | The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis. |
| To evaluate the effect of Obex® on the waist and hip ratio. | Six months | Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol. |
| To evaluate the effect of Obex® on the waist and height ratio. | Six months | Waist and height ratio will be measured. |
Countries
Cuba
Outcome results
None listed