Evaluation of Obex® in Overweight and Obesity
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Obex
- Registration Number
- NCT03541005
- Lead Sponsor
- Catalysis SL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. Obex Obex a nutritional supplement Obex® 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.
- Primary Outcome Measures
Name Time Method 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).
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).
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 Outcome Measures
Name Time Method 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 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 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 Body Mass Index (BMI). Six months The BMI will be measured by Quételet index.
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.
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 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 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 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 fasting insulin levels. Six months The insulin 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.
Trial Locations
- Locations (1)
National Institute of Endocrinology
🇨🇺Havana, La Habana, Cuba