Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

NCT ID: NCT02337933

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

Brief 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.

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial in 24 patients of both sexes aged between 30 and 60 years, with a diagnosis of metabolic syndrome according to the modified International Diabetes Federation (IDF) criteria, without treatment.

They will be assigned randomly two groups of 12 patients, each to receive 150 mg of ursolic acid or placebo before breakfast for 12 weeks.

Insulin sensitivity will be calculated by Matsuda Index with dates from glucose and insulin levels from Oral Glucose Tolerance Test; Waist circumference will be measured; triglycerides and High density lipoprotein (HDL-C) and blood pressure will be evaluated before and after intervention in both groups.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.

This protocol was approved by a local ethics committee (CEI/075/2014) and written informed consent will be obtained from all volunteers.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ursolic acid

Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks

Group Type: EXPERIMENTAL

Ursolic acid

Intervention Type: DRUG

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

Placebo

Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Ursolic acid

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Urson; Prunol; Micromerol; Malol; Calcined magnesia

Eligibility Criteria

Inclusion Criteria

• Informed consent signed
• Patients both sexes
• Age between 30 and 60 years
• Metabolic Syndrome according to the IDF criteria:
• Waist circumference Man ≥90 cm, Woman ≥80 cm; and two of the following criteria:
• High density lipoprotein Man ≤40 mg/dL, Woman ≤50 mg/dL;
• Fasting glucose ≥100 mg/dL;
• Triglycerides ≥150 mg/dL;
• Blood pressure ≥130/85 mmHg

Exclusion Criteria

• Women with confirmed or suspected pregnancy
• Women under lactation and/or puerperium
• Hypersensibility to ursolic acid o calcined magnesia
• Physical impossibility for taking pills
• Known uncontrolled renal, hepatic, heart or thyroid diseased
• Previous treatment for the metabolic syndrome components
• Body Mass Index ≥39.9 kg/m2
• Fasting glucose ≥126 mg/dL
• Triglycerides ≥500 mg/dL
• Total cholesterol ≥240 mg/dL
• Low density lipoprotein (c-LDL) ≥190 mg/dL
• Blood Pressure ≥140/90 mmHg

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Manuel González Ortiz

Researcher Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel González-Ortíz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

UA-MS

Identifier Type: -

Identifier Source: org_study_id