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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irvingia gabonensis | Experimental | Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks |
|
| Placebo | Placebo Comparator | Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irvingia gabonensis | Dietary Supplement | Intervention will be administered 30 minutes before meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose Levels at Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 12 weeks |
| Triglycerides Levels at Week 12 | Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight at Week 12 | The body weight will be measured at baseline and week 12 with a bioimpedance balance. | 12 weeks |
| Body Mass Index at Week 12 | The body mass index will be calculated at baseline and week 12 with the Quetelet index |
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Inclusion Criteria:
And two of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapéutica Experimental y ClÃnica | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Irvingia Gabonensis | Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals |
| FG001 | Placebo | Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Irvingia Gabonensis | Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Glucose Levels at Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | mmol/L | 12 weeks |
|
Adverse events were collected during the 12 weeks of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irvingia Gabonensis | Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA | +52 3310585200 | 34212 | uice@prodigy.net.mx |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C051375 | dikanut |
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This is a study with two groups of patients with metabolic syndrome. One group received Irvingia Gabonensis and the other received placebo as control.
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| Placebo | Other | Intervention will be administered 30 minutes before meals |
|
|
| 12 weeks |
| 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion | 12 weeks |
| 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 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | 12 weeks |
| 12 weeks |
| Total Cholesterol at Week 12 | Total cholesterol will be estimated bye standardized techniques at baseline and week 12 | 12 weeks |
| 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 |
| Aspartate Aminotransferase at Week 12 | The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12 | 12 weeks |
| Alanine Aminotransferase at Week 12 | The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12 | 12 weeks |
| Creatinine at Week 12 | Creatinine levels will be measured at baseline and week 12 with standardized techniques | 12 weeks |
| Uric Acid at Week 12 | Uric acid levels will be measured at baseline and week 12 with standardized techniques | 12 weeks |
Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks
Placebo: Intervention will be administered 30 minutes before meals
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasting glucose | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoproteins (HDL-c) | Mean | Standard Deviation | mmol/L |
|
| Systolic blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Waist circumference | Mean | Standard Deviation | centimeters |
|
| First phase of insulin secretion | 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 | Mean | Standard Deviation | index |
|
| Total insulin secretion | 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 | Mean | Standard Deviation | index |
|
| Total insulin sensitivity | 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 | Mean | Standard Deviation | index |
|
| Body weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Total cholesterol | Mean | Standard Deviation | mmol/L |
|
| Low density lipoproteins (LDL-c) | Mean | Standard Deviation | mmol/L |
|
| Alanine aminotransferase (ALT) | Mean | Standard Deviation | U/L |
|
| Aspartate aminotransferase (AST) | Mean | Standard Deviation | U/L |
|
| Creatinine | Mean | Standard Deviation | umol/L |
|
| Uric acid | Mean | Standard Deviation | umol/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Triglycerides Levels at Week 12 | Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | mmol/L | 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 | Posted | Mean | Standard Deviation | mmol/L | 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 | Posted | Mean | Standard Deviation | mmHg | 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 | Posted | Mean | Standard Deviation | mmHg | 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 | Posted | Mean | Standard Deviation | centimeters | 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 | Posted | Mean | Standard Deviation | index | 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion | Posted | Mean | Standard Deviation | index | 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 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | Posted | Mean | Standard Deviation | index | 12 weeks |
|
|
|
|
| Secondary | Body Weight at Week 12 | The body weight will be measured at baseline and week 12 with a bioimpedance balance. | Posted | Mean | Standard Deviation | kilograms | 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 | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks |
|
|
|
|
| Secondary | Total Cholesterol at Week 12 | Total cholesterol will be estimated bye standardized techniques at baseline and week 12 | Posted | Mean | Standard Deviation | mmol/L | 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 | Posted | Mean | Standard Deviation | mmol/L | 12 weeks |
|
|
|
|
| Secondary | Aspartate Aminotransferase at Week 12 | The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12 | Posted | Mean | Standard Deviation | U/L | 12 weeks |
|
|
|
|
| Secondary | Alanine Aminotransferase at Week 12 | The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12 | Posted | Mean | Standard Deviation | U/L | 12 weeks |
|
|
|
|
| Secondary | Creatinine at Week 12 | Creatinine levels will be measured at baseline and week 12 with standardized techniques | Posted | Mean | Standard Deviation | umol/L | 12 weeks |
|
|
|
|
| Secondary | Uric Acid at Week 12 | Uric acid levels will be measured at baseline and week 12 with standardized techniques | Posted | Mean | Standard Deviation | umol/L | 12 weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo | Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals | 0 | 12 | 0 | 12 | 2 | 12 |
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Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.391 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.721 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.238 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.801 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.752 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.910 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.953 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.807 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.350 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.229 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.955 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.470 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.436 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.949 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.401 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.791 |
The threshold for statistical significance was p=0.05 |
| Superiority |