Evaluation of Obex® in Overweight and Obesity

Last updated: October 20, 2021
Sponsor: Catalysis SL
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03541005
OBEX-CAT-2018
  • Ages 20-65
  • All Genders

Study 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

Inclusion Criteria:

  • Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 andless 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 duringGlucose Tolerance Test (OGTT).
  • Written informed consent of participation in the study.

Exclusion

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 bodyweight.
  • 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 orsome 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

Total Participants: 160
Study Start date:
October 01, 2018
Estimated Completion Date:
July 03, 2021

Connect with a study center

  • National Institute of Endocrinology

    Havana, La Habana 10400
    Cuba

    Site Not Available

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