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

Not Applicable

Completed

Conditions: Metabolic Syndrome X

Interventions: Other: Placebo
Dietary Supplement: Irvingia gabonensis

Registration Number: NCT02354339

Lead Sponsor: University of Guadalajara

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks
Irvingia gabonensis	Irvingia gabonensis	Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Primary Outcome Measures

Name	Time	Method
Triglycerides Levels at Week 12	12 weeks	Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Fasting Glucose Levels at Week 12	12 weeks	Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
High Density Lipoprotein (HDL-C) Levels at Week 12	12 weeks	The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Total Insulin Secretion at Week 12	12 weeks	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
Systolic Blood Pressure at Week 12	12 weeks	The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Diastolic Blood Pressure at Week 12.	Baseline. Week 12	The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Total Insulin Sensitivity at Week 12	12 weeks	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
Waist Circumference at Week 12	12 weeks	The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape
First Phase of Insulin Secretion at Week 12	12 weeks	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

Secondary Outcome Measures

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