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

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354339
• Other study ID #: MS-IGABONENSIS
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2020
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Irvingia gabonensis
Intervention will be administered 30 minutes before meals

Other:
• Placebo
Intervention will be administered 30 minutes before meals

Locations

Country	Name	City	State
Mexico	Instituto de Terapéutica Experimental y Clínica	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Glucose Levels at Week 12	Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	12 weeks
Primary	Triglycerides Levels at Week 12	Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 (?ABC insulin/?ABC glucose), the entered values reflect the total insulin secretion	12 weeks
Primary	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 / vglucose 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	Body Weight at Week 12	The body weight will be measured at baseline and week 12 with a bioimpedance balance.	12 weeks
Secondary	Body Mass Index at Week 12	The body mass index will be calculated at baseline and week 12 with the Quetelet index	12 weeks
Secondary	Total Cholesterol at Week 12	Total cholesterol will be estimated bye standardized techniques at baseline and week 12	12 weeks
Secondary	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
Secondary	Aspartate Aminotransferase at Week 12	The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12	12 weeks
Secondary	Alanine Aminotransferase at Week 12	The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12	12 weeks
Secondary	Creatinine at Week 12	Creatinine levels will be measured at baseline and week 12 with standardized techniques	12 weeks
Secondary	Uric Acid at Week 12	Uric acid levels will be measured at baseline and week 12 with standardized techniques	12 weeks