Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2018-10-01
2021-07-03
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Obex
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.
Obex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
Placebo
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.
Placebo
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Interventions
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Obex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
Placebo
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Catalysis SL
INDUSTRY
Responsible Party
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Principal Investigators
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Roselin Valle Cabrera, BSc.
Role: STUDY_DIRECTOR
National Coordinator Center of Clinical Trials (CENCEC)
Locations
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National Institute of Endocrinology
Havana, La Habana, Cuba
Countries
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References
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Cabrera-Rode E, Cubas-Duenas I, Acosta JR, Hernandez JC, Gonzalez AIC, Calero TMG, Dominguez YA, Rodriguez JH, Rodriguez ADR, Alvarez Alvarez A, Valdes RE, Espinosa LJ, Belent OT, Benavides ZB, Estevez ES, Rodriguez YA, Del Valle Rodriguez J, Julia SM. Efficacy and safety of Obex(R) in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial. BMC Complement Med Ther. 2023 Feb 20;23(1):58. doi: 10.1186/s12906-023-03847-7.
Other Identifiers
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OBEX-CAT-2018
Identifier Type: -
Identifier Source: org_study_id