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

NCT ID: NCT02354339

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Irvingia gabonensis

Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Group Type: EXPERIMENTAL

Irvingia gabonensis

Intervention Type: DIETARY_SUPPLEMENT

Intervention will be administered 30 minutes before meals

Placebo

Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intervention will be administered 30 minutes before meals

Interventions

Irvingia gabonensis

Intervention will be administered 30 minutes before meals

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention will be administered 30 minutes before meals

Intervention Type: OTHER

Other Intervention Names

African mango; calcined magnesia

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Manuel González Ortiz

Researcher Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MANUEL GONZALEZ, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

MS-IGABONENSIS

Identifier Type: -

Identifier Source: org_study_id