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Evaluation of Obex® in Overweight and Obesity

NCT03541005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-10-21

No results posted yet for this 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.

Conditions

  • Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

Obex

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Roselin Valle Cabrera, BSc. · National Coordinator Center of Clinical Trials (CENCEC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-09-01
Completion
2021-07-03

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541005 on ClinicalTrials.gov