Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: Irvingia gabonensis
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients both sexes Age between 30 and 60 years Metabolic syndrome according IDF modified criteria Waist circumference: Men ≥90 cm, women ≥80 cm And two of the following criteria: HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL Fasting glucose ≥100 mg/dL Triglycerides ≥150 mg/dL Blood pressure ≥130/85 mmHg Informed consent signed Exclusion Criteria: Women with confirmed or suspected pregnancy Women under lactation and/or puerperium Known hypersensibility to Irvingia gabonensis Physical impossibility for taking pills Known uncontrolled renal, hepatic, heart or thyroid disease 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 LDL-C ≥190 mg/dL Blood pressure ≥140/90 mmHg

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irvingia gabonensis<br>Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks | Dietary Supplement: Irvingia gabonensis<br>* Intervention will be administered 30 minutes before meals<br>* Other names: African mango;|
| Placebo Comparator: Placebo<br>Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks | Other: Placebo<br>* Intervention will be administered 30 minutes before meals<br>* Other names: calcined magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose Levels at Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 12 weeks | 
| Triglycerides Levels at Week 12 | Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 12 weeks | 
| High Density Lipoprotein (HDL-C) Levels at Week 12 | The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 12 weeks | 
| Systolic Blood Pressure at Week 12 | The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer | 12 weeks | 
| Diastolic Blood Pressure at Week 12. | The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer | Baseline. Week 12 | 
| Waist Circumference at Week 12 | The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape | 12 weeks | 
| First Phase of Insulin Secretion at Week 12 | The first phase of insulin secretion will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion | 12 weeks | 
| Total Insulin Secretion at Week 12 | Total insulin secretion will be calculated at baseline and week 12 with the insulinogenic index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion | 12 weeks | 
| Total Insulin Sensitivity at Week 12 | Insulin sensitivity will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight at Week 12 | The body weight will be measured at baseline and week 12 with a bioimpedance balance. | 12 weeks | 
| Body Mass Index at Week 12 | The body mass index will be calculated at baseline and week 12 with the Quetelet index | 12 weeks | 
| Total Cholesterol at Week 12 | Total cholesterol will be estimated bye standardized techniques at baseline and week 12 | 12 weeks | 
| Low Density Lipoproteins (LDL-C) at Week 12 | The LDL-C will be calculated at baseline and week 12 with the Friedewald formula | 12 weeks | 
| Aspartate Aminotransferase at Week 12 | The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12 | 12 weeks | 
| Alanine Aminotransferase at Week 12 | The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12 | 12 weeks | 
| Creatinine at Week 12 | Creatinine levels will be measured at baseline and week 12 with standardized techniques | 12 weeks | 
| Uric Acid at Week 12 | Uric acid levels will be measured at baseline and week 12 with standardized techniques | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Irvingia gabonensis, African mango, Insulin resistance