Clinical trial NCT03541005: Evaluation of Obex® in Overweight and Obesity
Official title: Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Nutritional supplement
Weight loss
waist
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Gynoid fat distribution.

Primary outcomes:
measure: Change From Baseline in Body Weight.
timeFrame: Six months
measure: Change From Baseline in Waist Circumference at Week 24.
timeFrame: Six months
measure: To evaluate the effect of Obex® on fasting glucose levels.
timeFrame: Six months
Secondary outcomes:
measure: To evaluate the effect of Obex® on Body Mass Index (BMI).
timeFrame: Six months
measure: To evaluate the effect of Obex® on the waist and hip ratio.
timeFrame: Six months
measure: To evaluate the effect of Obex® on the waist and height ratio.
timeFrame: Six months
measure: To evaluate the effect of Obex® on arterial blood pressures (BP).
timeFrame: Six months
measure: To evaluate the effect of Obex® on fasting insulin levels.
timeFrame: Six months
measure: To evaluate the effect of Obex® on insulin resistance.
timeFrame: Six months
measure: To evaluate the effect of Obex® on insulin sensitivity.
timeFrame: Six months
measure: To evaluate the effect of Obex® on β-cell function.
timeFrame: Six months
measure: To evaluate the effect of Obex® on cholesterol.
timeFrame: Six months
measure: To evaluate the effect of Obex® on hepatic enzymes.
timeFrame: Six months
measure: To evaluate the effect of Obex® on creatinine and uric acid concentrations.
timeFrame: Six months
measure: To evaluate the effect of Obex® on haemoglobin levels.
timeFrame: Six months
measure: To evaluate the effect of Obex® on Conicity Index (CI)
timeFrame: Six months
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: National Institute of Endocrinology
state: La Habana
Study officials:
affiliation: National Coordinator Center of Clinical Trials (CENCEC)
name: Roselin Valle Cabrera, BSc.
role: STUDY_DIRECTOR
References: