Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Intervention: Ursolic acid; Placebo
Intervention description: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast; Calcined magnesia capsules of 150 mg, once a day before breakfast
Intervention MeSH terms: Ursolic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metabolic Syndrome; Central Obesity; Insulin Sensitivity; Ursolic Acid; Triterpenoid

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.
    

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