Metabolic Syndrome X
Conditions
Keywords
Metabolic Syndrome, Irvingia gabonensis, African mango, Insulin resistance
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.
Interventions
DIETARY_SUPPLEMENTIrvingia gabonensis
Intervention will be administered 30 minutes before meals
OTHERPlacebo
Intervention will be administered 30 minutes before meals
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Insulin Sensitivity at Week 12 | 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 |
| Fasting Glucose Levels at Week 12 | 12 weeks | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Triglycerides Levels at Week 12 | 12 weeks | Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| High Density Lipoprotein (HDL-C) Levels at Week 12 | 12 weeks | The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Systolic Blood Pressure at Week 12 | 12 weeks | The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer |
| Diastolic Blood Pressure at Week 12. | Baseline. Week 12 | The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer |
| Waist Circumference at Week 12 | 12 weeks | The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape |
| First Phase of Insulin Secretion at Week 12 | 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 |
| Total Insulin Secretion at Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index at Week 12 | 12 weeks | The body mass index will be calculated at baseline and week 12 with the Quetelet index |
| Total Cholesterol at Week 12 | 12 weeks | Total cholesterol will be estimated bye standardized techniques at baseline and week 12 |
| Low Density Lipoproteins (LDL-C) at Week 12 | 12 weeks | The LDL-C will be calculated at baseline and week 12 with the Friedewald formula |
| Aspartate Aminotransferase at Week 12 | 12 weeks | The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12 |
| Alanine Aminotransferase at Week 12 | 12 weeks | The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12 |
| Creatinine at Week 12 | 12 weeks | Creatinine levels will be measured at baseline and week 12 with standardized techniques |
| Uric Acid at Week 12 | 12 weeks | Uric acid levels will be measured at baseline and week 12 with standardized techniques |
| Body Weight at Week 12 | 12 weeks | The body weight will be measured at baseline and week 12 with a bioimpedance balance. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Irvingia Gabonensis | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 7.1 | 47.8 years STANDARD_DEVIATION 6.5 | 47.8 years STANDARD_DEVIATION 6.1 |
| Alanine aminotransferase (ALT) | 27.0 U/L STANDARD_DEVIATION 12.2 | 30.4 U/L STANDARD_DEVIATION 20.8 | 33.8 U/L STANDARD_DEVIATION 27.1 |
| Aspartate aminotransferase (AST) | 27.5 U/L STANDARD_DEVIATION 16.7 | 30.7 U/L STANDARD_DEVIATION 18.5 | 33.9 U/L STANDARD_DEVIATION 20.4 |
| Body Mass Index | 32.0 kg/m^2 STANDARD_DEVIATION 4.4 | 31.6 kg/m^2 STANDARD_DEVIATION 4.1 | 31.2 kg/m^2 STANDARD_DEVIATION 3.9 |
| Body weight | 80.6 kilograms STANDARD_DEVIATION 13 | 79.5 kilograms STANDARD_DEVIATION 11.1 | 78.5 kilograms STANDARD_DEVIATION 9.2 |
| Creatinine | 70.7 umol/L STANDARD_DEVIATION 17.7 | 70.7 umol/L STANDARD_DEVIATION 17.7 | 70.7 umol/L STANDARD_DEVIATION 17.7 |
| Diastolic Blood Pressure | 78.9 mmHg STANDARD_DEVIATION 7.4 | 80.8 mmHg STANDARD_DEVIATION 7.8 | 82.7 mmHg STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting glucose | 6.04 mmol/L STANDARD_DEVIATION 0.7 | 5.9 mmol/L STANDARD_DEVIATION 0.6 | 5.9 mmol/L STANDARD_DEVIATION 0.5 |
| First phase of insulin secretion | 1306 index STANDARD_DEVIATION 1500 | 1670.9 index STANDARD_DEVIATION 1831 | 2036 index STANDARD_DEVIATION 2115 |
| High Density Lipoproteins (HDL-c) | 1.4 mmol/L STANDARD_DEVIATION 0.3 | 1.5 mmol/L STANDARD_DEVIATION 0.4 | 1.6 mmol/L STANDARD_DEVIATION 0.4 |
| Low density lipoproteins (LDL-c) | 3.4 mmol/L STANDARD_DEVIATION 1 | 3.2 mmol/L STANDARD_DEVIATION 0.7 | 3.0 mmol/L STANDARD_DEVIATION 0.9 |
| Region of Enrollment Mexico | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 10 Participants | 17 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
| Systolic blood Pressure | 125.3 mmHg STANDARD_DEVIATION 13 | 126.8 mmHg STANDARD_DEVIATION 10.9 | 128.4 mmHg STANDARD_DEVIATION 8.5 |
| Total cholesterol | 5.7 mmol/L STANDARD_DEVIATION 0.6 | 5.5 mmol/L STANDARD_DEVIATION 0.7 | 5.4 mmol/L STANDARD_DEVIATION 0.7 |
| Total insulin secretion | 0.5 index STANDARD_DEVIATION 0.2 | 0.63 index STANDARD_DEVIATION 0.37 | 0.8 index STANDARD_DEVIATION 0.5 |
| Total insulin sensitivity | 2.8 index STANDARD_DEVIATION 1.8 | 2.3 index STANDARD_DEVIATION 1.5 | 1.9 index STANDARD_DEVIATION 0.9 |
| Triglycerides | 2.5 mmol/L STANDARD_DEVIATION 1.2 | 2.4 mmol/L STANDARD_DEVIATION 0.9 | 2.2 mmol/L STANDARD_DEVIATION 0.6 |
| Uric acid | 374.7 umol/L STANDARD_DEVIATION 148.7 | 383.7 umol/L STANDARD_DEVIATION 110 | 392.6 umol/L STANDARD_DEVIATION 59.5 |
| Waist circumference | 94.0 centimeters STANDARD_DEVIATION 8 | 95.5 centimeters STANDARD_DEVIATION 8.5 | 96.9 centimeters STANDARD_DEVIATION 9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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
Time frame: Baseline. Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Diastolic Blood Pressure at Week 12. | 77.5 mmHg | Standard Deviation 7.3 |
| Placebo | Diastolic Blood Pressure at Week 12. | 81.1 mmHg | Standard Deviation 11.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis groupp-value: 0.452Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo groupp-value: 0.801Wilcoxon (Mann-Whitney)
Primary
Fasting Glucose Levels at Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Fasting Glucose Levels at Week 12 | 5.7 mmol/L | Standard Deviation 0.7 |
| Placebo | Fasting Glucose Levels at Week 12 | 5.9 mmol/L | Standard Deviation 0.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis groupp-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo groupp-value: 0.85Wilcoxon (Mann-Whitney)
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | First Phase of Insulin Secretion at Week 12 | 1382 index | Standard Deviation 1119 |
| Placebo | First Phase of Insulin Secretion at Week 12 | 1690 index | Standard Deviation 1070 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis groupp-value: 0.791Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo groupp-value: 0.91Wilcoxon (Mann-Whitney)
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | High Density Lipoprotein (HDL-C) Levels at Week 12 | 1.9 mmol/L | Standard Deviation 0.4 |
| Placebo | High Density Lipoprotein (HDL-C) Levels at Week 12 | 1.5 mmol/L | Standard Deviation 0.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis groupp-value: 0.206Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo groupp-value: 0.721Wilcoxon (Mann-Whitney)
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Systolic Blood Pressure at Week 12 | 123.5 mmHg | Standard Deviation 10.6 |
| Placebo | Systolic Blood Pressure at Week 12 | 126.5 mmHg | Standard Deviation 12.1 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis groupp-value: 0.371Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo groupp-value: 0.238Wilcoxon (Mann-Whitney)
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Total Insulin Secretion at Week 12 | 0.57 index | Standard Deviation 0.2 |
| Placebo | Total Insulin Secretion at Week 12 | 0.8 index | Standard Deviation 0.3 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis groupp-value: 0.458Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo groupp-value: 0.953Wilcoxon (Mann-Whitney)
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Total Insulin Sensitivity at Week 12 | 3.5 index | Standard Deviation 3.7 |
| Placebo | Total Insulin Sensitivity at Week 12 | 1.9 index | Standard Deviation 1.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis groupp-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo groupp-value: 0.807Wilcoxon (Mann-Whitney)
Primary
Triglycerides Levels at Week 12
Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Triglycerides Levels at Week 12 | 2.0 mmol/L | Standard Deviation 1.1 |
| Placebo | Triglycerides Levels at Week 12 | 2.4 mmol/L | Standard Deviation 1.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis groupp-value: 0.012Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo groupp-value: 0.391Wilcoxon (Mann-Whitney)
Primary
Waist Circumference at Week 12
The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Waist Circumference at Week 12 | 91.1 centimeters | Standard Deviation 8.2 |
| Placebo | Waist Circumference at Week 12 | 97.3 centimeters | Standard Deviation 8.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis groupp-value: 0.005Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo groupp-value: 0.752Wilcoxon (Mann-Whitney)
Secondary
Alanine Aminotransferase at Week 12
The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Alanine Aminotransferase at Week 12 | 27.3 U/L | Standard Deviation 14.1 |
| Placebo | Alanine Aminotransferase at Week 12 | 31.9 U/L | Standard Deviation 23.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis groupp-value: 0.989Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of ALT on placebo groupp-value: 0.949Wilcoxon (Mann-Whitney)
Secondary
Aspartate Aminotransferase at Week 12
The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Aspartate Aminotransferase at Week 12 | 27.5 U/L | Standard Deviation 15.8 |
| Placebo | Aspartate Aminotransferase at Week 12 | 27.8 U/L | Standard Deviation 16.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis groupp-value: 0.91Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of AST on placebo groupp-value: 0.436Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index at Week 12
The body mass index will be calculated at baseline and week 12 with the Quetelet index
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Body Mass Index at Week 12 | 32.0 kg/m^2 | Standard Deviation 4.3 |
| Placebo | Body Mass Index at Week 12 | 31.4 kg/m^2 | Standard Deviation 3.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis groupp-value: 0.727Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of BMI on placebo groupp-value: 0.229Wilcoxon (Mann-Whitney)
Secondary
Body Weight at Week 12
The body weight will be measured at baseline and week 12 with a bioimpedance balance.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Body Weight at Week 12 | 80.5 kilograms | Standard Deviation 12.8 |
| Placebo | Body Weight at Week 12 | 79.0 kilograms | Standard Deviation 9.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis groupp-value: 0.604Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of body weight on placebo groupp-value: 0.35Wilcoxon (Mann-Whitney)
Secondary
Creatinine at Week 12
Creatinine levels will be measured at baseline and week 12 with standardized techniques
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Creatinine at Week 12 | 61.9 umol/L | Standard Deviation 17.7 |
| Placebo | Creatinine at Week 12 | 70.7 umol/L | Standard Deviation 17.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis groupp-value: 0.095Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo groupp-value: 0.401Wilcoxon (Mann-Whitney)
Secondary
Low Density Lipoproteins (LDL-C) at Week 12
The LDL-C will be calculated at baseline and week 12 with the Friedewald formula
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Low Density Lipoproteins (LDL-C) at Week 12 | 3.2 mmol/L | Standard Deviation 0.9 |
| Placebo | Low Density Lipoproteins (LDL-C) at Week 12 | 2.8 mmol/L | Standard Deviation 0.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis groupp-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo groupp-value: 0.47Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol at Week 12
Total cholesterol will be estimated bye standardized techniques at baseline and week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Total Cholesterol at Week 12 | 5.8 mmol/L | Standard Deviation 0.9 |
| Placebo | Total Cholesterol at Week 12 | 5.5 mmol/L | Standard Deviation 0.7 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis groupp-value: 0.151Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo groupp-value: 0.955Wilcoxon (Mann-Whitney)
Secondary
Uric Acid at Week 12
Uric acid levels will be measured at baseline and week 12 with standardized techniques
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irvingia Gabonensis | Uric Acid at Week 12 | 345.0 umol/L | Standard Deviation 53.5 |
| Placebo | Uric Acid at Week 12 | 404.5 umol/L | Standard Deviation 119 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis groupp-value: 0.91Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo groupp-value: 0.791Wilcoxon (Mann-Whitney)