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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354339
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, 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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Irvingia gabonensis Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Irvingia gabonensis
Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks
Dietary Supplement: Irvingia gabonensis
Intervention will be administered 30 minutes before meals
Other Name: African mango

Placebo Comparator: Placebo
Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks
Other: Placebo
Intervention will be administered 30 minutes before meals
Other Name: calcined magnesia




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354339


Locations
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Mexico
Instituto de Terapéutica Experimental y Clínica
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: MANUEL GONZALEZ, PhD University of Guadalajara
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Responsible Party: Manuel González Ortiz, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02354339    
Other Study ID Numbers: MS-IGABONENSIS
First Posted: February 3, 2015    Key Record Dates
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel González Ortiz, University of Guadalajara:
Metabolic Syndrome
Irvingia gabonensis
African mango
Insulin resistance
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents