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OpenTrials
Completed

NCT Number: NCT03541005

Evaluation of Obex® in Overweight and Obesity

* 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Endocrinology

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obex

Dietary Supplement

After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex

Placebo

Dietary Supplement

After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.

Primary outcomes

  1. Change From Baseline in Body Weight.

    Time frame: 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).

  2. Change From Baseline in Waist Circumference at Week 24.

    Time frame: 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).

  3. To evaluate the effect of Obex® on fasting glucose levels.

    Time frame: Six months

    The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.

Secondary outcomes

  1. To evaluate the effect of Obex® on Body Mass Index (BMI).

    Time frame: Six months

    The BMI will be measured by Quételet index.

  2. To evaluate the effect of Obex® on the waist and hip ratio.

    Time frame: Six months

    Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol.

  3. To evaluate the effect of Obex® on the waist and height ratio.

    Time frame: Six months

    Waist and height ratio will be measured.

  4. To evaluate the effect of Obex® on arterial blood pressures (BP).

    Time frame: Six months

    The arterial BP will be evaluated by the doctor.

  5. To evaluate the effect of Obex® on fasting insulin levels.

    Time frame: Six months

    The insulin levels will be evaluated by blood analysis.

  6. To evaluate the effect of Obex® on insulin resistance.

    Time frame: Six months

    Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5).

  7. To evaluate the effect of Obex® on insulin sensitivity.

    Time frame: 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]).

  8. To evaluate the effect of Obex® on β-cell function.

    Time frame: 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).

  9. To evaluate the effect of Obex® on cholesterol.

    Time frame: Six months

    The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.

  10. To evaluate the effect of Obex® on hepatic enzymes.

    Time frame: Six months

    The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis.

  11. To evaluate the effect of Obex® on creatinine and uric acid concentrations.

    Time frame: Six months

    The creatinine and uric acid levels will be evaluated by blood analysis.

  12. To evaluate the effect of Obex® on haemoglobin levels.

    Time frame: Six months

    The haemoglobin levels will be evaluated by blood analysis.

  13. To evaluate the effect of Obex® on Conicity Index (CI)

    Time frame: Six months

    CI will be measured by index.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
May 30, 2018
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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