Evaluation of Obex® in Overweight and Obesity

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Obex

Study type: Interventional

Funder types: Industry

Identifiers

NCT03541005

OBEX-CAT-2018

Details and patient eligibility

About

• 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.

Enrollment: 160 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Obex

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Obex

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo