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

• Sponsor: University of Guadalajara (Other)
• Overall Status: Completed
• CT.gov ID: NCT02354339
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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.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: Jan 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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 Names: 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 Names: calcined magnesia

Outcome Measures

Primary Outcome Measures

1. Fasting Glucose Levels at Week 12 [12 weeks]

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

2. Triglycerides Levels at Week 12 [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 [12 weeks]

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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

Secondary Outcome Measures

1. Body Weight at Week 12 [12 weeks]

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

2. Body Mass Index at Week 12 [12 weeks]

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

3. Total Cholesterol at Week 12 [12 weeks]

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

4. 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

5. Aspartate Aminotransferase at Week 12 [12 weeks]

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

6. Alanine Aminotransferase at Week 12 [12 weeks]

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

7. Creatinine at Week 12 [12 weeks]

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

8. Uric Acid at Week 12 [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Terapéutica Experimental y Clínica	Guadalajara	Jalisco	Mexico	44340

Sponsors and Collaborators

• University of Guadalajara

Investigators

• Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manuel González Ortiz, Researcher Professor, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT02354339
• Other Study ID Numbers: MS-IGABONENSIS
• First Posted: Feb 3, 2015
• Last Update Posted: Oct 8, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manuel González Ortiz, Researcher Professor, University of Guadalajara: Metabolic Syndrome; Irvingia gabonensis; African mango; Insulin resistance
• Additional relevant MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome; Magnesium Oxide

Study Results

Participant Flow

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Irvingia Gabonensis	Placebo	Total
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (7.1)	47.8 (6.1)	47.8 (6.5)
Sex: Female, Male (Count of Participants)
Female	10 83.3%	7 58.3%	17 70.8%
Male	2 16.7%	5 41.7%	7 29.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 100%	12 100%	24 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Mexico	12 100%	12 100%	24 100%
Fasting glucose (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	6.04 (0.7)	5.9 (0.5)	5.9 (0.6)
Triglycerides (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	2.5 (1.2)	2.2 (0.6)	2.4 (0.9)
High Density Lipoproteins (HDL-c) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	1.4 (0.3)	1.6 (0.4)	1.5 (0.4)
Systolic blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	125.3 (13.0)	128.4 (8.5)	126.8 (10.9)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	78.9 (7.4)	82.7 (8.0)	80.8 (7.8)
Waist circumference (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	94.0 (8.0)	96.9 (9.0)	95.5 (8.5)
First phase of insulin secretion (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	1306 (1500)	2036 (2115)	1670.9 (1831.0)
Total insulin secretion (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	0.5 (0.2)	0.8 (0.5)	0.63 (0.37)
Total insulin sensitivity (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	2.8 (1.8)	1.9 (0.9)	2.3 (1.5)
Body weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	80.6 (13.0)	78.5 (9.2)	79.5 (11.1)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.0 (4.4)	31.2 (3.9)	31.6 (4.1)
Total cholesterol (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	5.7 (0.6)	5.4 (0.7)	5.5 (0.7)
Low density lipoproteins (LDL-c) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	3.4 (1.0)	3.0 (0.9)	3.2 (0.7)
Alanine aminotransferase (ALT) (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	27.0 (12.2)	33.8 (27.1)	30.4 (20.8)
Aspartate aminotransferase (AST) (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	27.5 (16.7)	33.9 (20.4)	30.7 (18.5)
Creatinine (umol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol/L]	70.7 (17.7)	70.7 (17.7)	70.7 (17.7)
Uric acid (umol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol/L]	374.7 (148.7)	392.6 (59.5)	383.7 (110.0)

Outcome Measures

1. Primary Outcome

Title	Fasting Glucose Levels at Week 12
Description	Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmol/L]	5.7 (0.7)	5.9 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.240
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Triglycerides Levels at Week 12
Description	Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	11
Mean (Standard Deviation) [mmol/L]	2.0 (1.1)	2.4 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.391
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	High Density Lipoprotein (HDL-C) Levels at Week 12
Description	The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmol/L]	1.9 (0.4)	1.5 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.206
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.721
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

Title	Systolic Blood Pressure at Week 12
Description	The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmHg]	123.5 (10.6)	126.5 (12.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.371
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.238
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Primary Outcome

Title	Diastolic Blood Pressure at Week 12.
Description	The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Time Frame	Baseline. Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmHg]	77.5 (7.3)	81.1 (11.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.452
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.801
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Primary Outcome

Title	Waist Circumference at Week 12
Description	The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [centimeters]	91.1 (8.2)	97.3 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.752
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Primary Outcome

Title	First Phase of Insulin Secretion at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [index]	1382 (1119)	1690 (1070)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	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 group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.791
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Primary Outcome

Title	Total Insulin Secretion at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [index]	0.57 (0.20)	0.8 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.458
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.953
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Primary Outcome

Title	Total Insulin Sensitivity at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [index]	3.5 (3.7)	1.9 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.470
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.807
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Secondary Outcome

Title	Body Weight at Week 12
Description	The body weight will be measured at baseline and week 12 with a bioimpedance balance.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [kilograms]	80.5 (12.8)	79.0 (9.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.604
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.350
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Body Mass Index at Week 12
Description	The body mass index will be calculated at baseline and week 12 with the Quetelet index
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [kg/m^2]	32.0 (4.3)	31.4 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.727
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.229
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Total Cholesterol at Week 12
Description	Total cholesterol will be estimated bye standardized techniques at baseline and week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmol/L]	5.8 (0.9)	5.5 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.151
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.955
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	Low Density Lipoproteins (LDL-C) at Week 12
Description	The LDL-C will be calculated at baseline and week 12 with the Friedewald formula
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [mmol/L]	3.2 (0.9)	2.8 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.350
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.470
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	Aspartate Aminotransferase at Week 12
Description	The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [U/L]	27.5 (15.8)	27.8 (16.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of AST on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.436
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	Alanine Aminotransferase at Week 12
Description	The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [U/L]	27.3 (14.1)	31.9 (23.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.989
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.949
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	Creatinine at Week 12
Description	Creatinine levels will be measured at baseline and week 12 with standardized techniques
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [umol/L]	61.9 (17.7)	70.7 (17.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.095
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.401
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Secondary Outcome

Title	Uric Acid at Week 12
Description	Uric acid levels will be measured at baseline and week 12 with standardized techniques
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Irvingia Gabonensis	Placebo
Arm/Group Description	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	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Measure Participants	12	12
Mean (Standard Deviation) [umol/L]	345.0 (53.5)	404.5 (119.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Irvingia Gabonensis
	Comments	Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.791
	Comments	The threshold for statistical significance was p=0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse events were collected during the 12 weeks of the study.
Arm/Group Title	Irvingia Gabonensis		Placebo
Arm/Group Description	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		Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
All Cause Mortality
	Irvingia Gabonensis		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Irvingia Gabonensis		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Irvingia Gabonensis		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		2/12 (16.7%)
Gastrointestinal disorders
Constipation	1/12 (8.3%)	1	2/12 (16.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.