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Completed

NCT Number: NCT02354339

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

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irvingia gabonensis

Dietary Supplement

Intervention will be administered 30 minutes before meals

Other names: African mango

Placebo

Other

Intervention will be administered 30 minutes before meals

Other names: calcined magnesia

Primary outcomes

  1. Fasting Glucose Levels at Week 12

    Time frame: 12 weeks

    Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  2. Triglycerides Levels at Week 12

    Time frame: 12 weeks

    Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  3. High Density Lipoprotein (HDL-C) Levels at Week 12

    Time frame: 12 weeks

    The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  4. Systolic Blood Pressure at Week 12

    Time frame: 12 weeks

    The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

  5. Diastolic Blood Pressure at Week 12.

    Time frame: Baseline. Week 12

    The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

  6. Waist Circumference at Week 12

    Time frame: 12 weeks

    The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape

  7. First Phase of Insulin Secretion at Week 12

    Time frame: 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

  8. Total Insulin Secretion at Week 12

    Time frame: 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

  9. Total Insulin Sensitivity at Week 12

    Time frame: 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

Secondary outcomes

  1. Body Weight at Week 12

    Time frame: 12 weeks

    The body weight will be measured at baseline and week 12 with a bioimpedance balance.

  2. Body Mass Index at Week 12

    Time frame: 12 weeks

    The body mass index will be calculated at baseline and week 12 with the Quetelet index

  3. Total Cholesterol at Week 12

    Time frame: 12 weeks

    Total cholesterol will be estimated bye standardized techniques at baseline and week 12

  4. Low Density Lipoproteins (LDL-C) at Week 12

    Time frame: 12 weeks

    The LDL-C will be calculated at baseline and week 12 with the Friedewald formula

  5. Aspartate Aminotransferase at Week 12

    Time frame: 12 weeks

    The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12

  6. Alanine Aminotransferase at Week 12

    Time frame: 12 weeks

    The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12

  7. Creatinine at Week 12

    Time frame: 12 weeks

    Creatinine levels will be measured at baseline and week 12 with standardized techniques

  8. Uric Acid at Week 12

    Time frame: 12 weeks

    Uric acid levels will be measured at baseline and week 12 with standardized techniques

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2015
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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