Clinical trial NCT02354339: Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Official title: Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome
Irvingia gabonensis
African mango
Insulin resistance
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting Glucose Levels at Week 12
timeFrame: 12 weeks
measure: Triglycerides Levels at Week 12
timeFrame: 12 weeks
measure: High Density Lipoprotein (HDL-C) Levels at Week 12
timeFrame: 12 weeks
measure: Systolic Blood Pressure at Week 12
timeFrame: 12 weeks
measure: Diastolic Blood Pressure at Week 12.
timeFrame: Baseline. Week 12
measure: Waist Circumference at Week 12
timeFrame: 12 weeks
measure: First Phase of Insulin Secretion at Week 12
timeFrame: 12 weeks
measure: Total Insulin Secretion at Week 12
timeFrame: 12 weeks
measure: Total Insulin Sensitivity at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Weight at Week 12
timeFrame: 12 weeks
measure: Body Mass Index at Week 12
timeFrame: 12 weeks
measure: Total Cholesterol at Week 12
timeFrame: 12 weeks
measure: Low Density Lipoproteins (LDL-C) at Week 12
timeFrame: 12 weeks
measure: Aspartate Aminotransferase at Week 12
timeFrame: 12 weeks
measure: Alanine Aminotransferase at Week 12
timeFrame: 12 weeks
measure: Creatinine at Week 12
timeFrame: 12 weeks
measure: Uric Acid at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Terapéutica Experimental y Clínica
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: MANUEL GONZALEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: