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Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

NCT02337933 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-10-08

Study results available
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Summary

The metabolic syndrome is characterized by the presence of overweight/obesity, insulin resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.

In the search for a pharmacological agent that can attend more components of the metabolic syndrome and above all improve insulin sensitivity to effectively prevent the development of CVD and DM2, ursolic acid is a promising compound.

Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some fruits like apple peel, and plants such as rosemary. There is scientific evidence of important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of lipids and glucose, as well as on the body weight and metabolic parameters. However, the results are not clear and the mechanisms are not fully elucidate.

The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity and metabolic syndrome.

Conditions

  • Metabolic Syndrome X

Interventions

DRUG

Ursolic acid

Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast

DRUG

Placebo

Calcined magnesia capsules of 150 mg, once a day before breakfast

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Manuel González-Ortíz, PhD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Mexico

Study Locations

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Entities

Drugs

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 NCT02337933 on ClinicalTrials.gov