Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The metabolic syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers from the disease and predispose the onset of diseases like cardiovascular
      disease and diabetes mellitus type 2.

      The first line of treatment for metabolic syndrome is diet and exercise but patients have a
      low attachment to the treatment, so pharmacologic therapy is required. There is no a single
      drug that could help to the treatment of all metabolic syndrome components.

      Irvingia gabonensis, better known as African mango, is widely consumed in central and western
      Africa, mainly the fruit and seeds. Besides being part of the diet of African the seeds have
      been used for the treatment of diseases such as dysentery, diabetes and as an analgesic.

      Resent investigations have demonstrated that an extract of African mango seeds induce
      significantly weight loss in subjects with obesity, and also improves some biochemical
      parameters such as glucose and the lipid profile.

      The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic syndrome,
      insulin secretion and insulin sensitivity.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, clinical trial is going to be carried out in
      24 patients of both sexes aged between 30 and 60 years, with diagnosis of metabolic syndrome
      according to the modified International Diabetes Federation (IDF) criteria (without diabetes
      and without previous treatment for metabolic syndrome components).

      The patients will be assigned randomly into two groups of 12 patients each. The patients will
      receive 150 mg of Irvingia gabonensis before breakfast and dinner (300 mg per day) or placebo
      during 12 weeks.

      Waist circumference, triglycerides, high density lipoproteins (HDL-c) and blood pressure will
      be evaluated before and after intervention in both groups.

      First phase of insulin secretion (Stumvoll index), total insulin secretion (Insulinogenic
      index) and Insulin sensitivity (Matsuda index) will be calculated from the concentration of
      glucose and insulin obtained from an Oral Glucose Tolerance Test.

      Data from statistical analysis will be presented through measures of central tendency and
      dispersion, mean and standard deviation for quantitative variables and frequencies and
      percentages for qualitative variables. Qualitative variables will be analyzed by X2. The
      inter group differences will be analyzed through Mann-Whitney U test and Wilcoxon Test for
      intra-group differences. Statistical significance will be considered with a p<0.05.

      This protocol was approved by a local ethics committee and written informed consent will be
      obtained from all volunteers.
    

Intervention name(s): Irvingia gabonensis; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Intervention will be administered 30 minutes before meals; Intervention will be administered 30 minutes before meals
Other intervention name(s): African mango; calcined magnesia
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a study with two groups of patients with metabolic syndrome. One group received Irvingia Gabonensis and the other received placebo as control.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Irvingia gabonensis; African mango; Insulin resistance