National Institute of Endocrinology
Havana, La Habana, 10400, Cuba
NCT Number: NCT03541005
* 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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Notify Me20 year–65 year
All sexes
Interventional
Phase 3
Havana, La Habana, 10400, Cuba
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
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).
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).
Time frame: Six months
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.
Time frame: Six months
The BMI will be measured by Quételet index.
Time frame: Six months
Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol.
Time frame: Six months
Waist and height ratio will be measured.
Time frame: Six months
The arterial BP will be evaluated by the doctor.
Time frame: Six months
The insulin levels will be evaluated by blood analysis.
Time frame: Six months
Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5).
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]).
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).
Time frame: Six months
The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.
Time frame: Six months
The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis.
Time frame: Six months
The creatinine and uric acid levels will be evaluated by blood analysis.
Time frame: Six months
The haemoglobin levels will be evaluated by blood analysis.
Time frame: Six months
CI will be measured by index.
Catalysis SL
Industry
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
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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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