Metabolic Syndrome XNCT02354339

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

A study testing Irvingia gabonensis in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Metabolic Syndrome X
What is being tested?: Irvingia gabonensis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteMexico
Study dates: Jan 2015to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Show all 10Show fewer

Fasting glucose ≥100 mg/dL
Triglycerides ≥150 mg/dL
Blood pressure ≥130/85 mmHg
Informed consent signed

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto de Terapéutica Experimental y Clínica
Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

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.

Read the 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.

Conditions: Metabolic Syndrome X
Being tested: Irvingia gabonensis, Placebo
Keywords: Metabolic Syndrome, Irvingia gabonensis, African mango, Insulin resistance
Medical subject headings: Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Irvingia gabonensisDietary supplement
Also called African mango
Intervention will be administered 30 minutes before meals
PlaceboOther
Also called calcined magnesia
Intervention will be administered 30 minutes before meals

Study groups in NCT02354339
Study group	Role	What they receive
Irvingia gabonensis	Experimental	Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Receives: Dietary Supplement: Irvingia gabonensis
Placebo	Placebo comparator	Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Glucose Levels at Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: 12 weeks
Triglycerides Levels at Week 12
Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks

Secondary outcomes (8)

Body Weight at Week 12
The body weight will be measured at baseline and week 12 with a bioimpedance balance.
Measured: 12 weeks
Body Mass Index at Week 12
The body mass index will be calculated at baseline and week 12 with the Quetelet index
Measured: 12 weeks
Total Cholesterol at Week 12
Total cholesterol will be estimated bye standardized techniques at baseline and week 12
Measured: 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
Measured: 12 weeks
Aspartate Aminotransferase at Week 12
The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12
Measured: 12 weeks
Alanine Aminotransferase at Week 12
The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12
Measured: 12 weeks
Creatinine at Week 12
Creatinine levels will be measured at baseline and week 12 with standardized techniques
Measured: 12 weeks
Uric Acid at Week 12
Uric acid levels will be measured at baseline and week 12 with standardized techniques
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jun 2016

First posted3 Feb 2015 (estimated)
Study startJan 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a study with two groups of patients with metabolic syndrome. One group received Irvingia Gabonensis and the other received placebo as control.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02354339
Sponsor's protocol ID: MS-IGABONENSIS
Status last verified: Sep 2020
First submitted: 29 Jan 2015
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
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Enrolling by invitationEarly Phase 1
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All Metabolic Syndrome X trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
ClinicalTrials.gov ID: NCT02354339
Acronym / sponsor ID: MS-IGABONENSIS
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome, Irvingia gabonensis, African mango, Insulin resistance
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Jan 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 3 Feb 2015 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic syndrome, insulin secretion and insulin sensitivity.

Detailed description

Waist circumference, triglycerides, high density lipoproteins (HDL-c) and blood pressure will be evaluated before and after intervention in both groups.

This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Irvingia gabonensis	Experimental	Dietary Supplement: Irvingia gabonensisIrvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks
Placebo	Placebo comparator	Other: PlaceboPlacebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Patients both sexes
Age between 30 and 60 years
Metabolic syndrome according IDF modified criteria
Waist circumference: Men ≥90 cm, women ≥80 cm
HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Irvingia gabonensisAlso: African mangoIntervention will be administered 30 minutes before meals	Dietary supplement	Irvingia gabonensis
PlaceboAlso: calcined magnesiaIntervention will be administered 30 minutes before meals	Other	Placebo

Primary outcome

Fasting Glucose Levels at Week 12
Time frame: 12 weeks
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Triglycerides Levels at Week 12
Time frame: 12 weeks
Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
High Density Lipoprotein (HDL-C) Levels at Week 12
Time frame: 12 weeks
The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Systolic Blood Pressure at Week 12
Time frame: 12 weeks
The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Diastolic Blood Pressure at Week 12.
Time frame: Baseline. Week 12
The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer
Waist Circumference at Week 12
Time frame: 12 weeks
The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape
First Phase of Insulin Secretion at Week 12
Time frame: 12 weeks
The first phase of insulin secretion will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Total Insulin Secretion at Week 12
Time frame: 12 weeks
Total insulin secretion will be calculated at baseline and week 12 with the insulinogenic index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Total Insulin Sensitivity at Week 12
Time frame: 12 weeks
Insulin sensitivity will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity

8 secondary outcomes

Body Weight at Week 12
Time frame: 12 weeks
Body Mass Index at Week 12
Time frame: 12 weeks
Total Cholesterol at Week 12
Time frame: 12 weeks
Low Density Lipoproteins (LDL-C) at Week 12
Time frame: 12 weeks
Aspartate Aminotransferase at Week 12
Time frame: 12 weeks
Alanine Aminotransferase at Week 12
Time frame: 12 weeks
Creatinine at Week 12
Time frame: 12 weeks
Uric Acid at Week 12
Time frame: 12 weeks

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irvingia Gabonensis	12	12
Placebo	12	12

Primary outcome: Fasting Glucose Levels at Week 12

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	Irvingia Gabonensis n = 12	Placebo n = 12
Value	5.7 (0.7)	5.9 (0.7)

Irvingia Gabonensis: p = 0.240, Wilcoxon (Mann-Whitney)
Placebo: p = 0.850, Wilcoxon (Mann-Whitney)

Primary outcome: Triglycerides Levels at Week 12

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	Irvingia Gabonensis n = 12	Placebo n = 11
Value	2.0 (1.1)	2.4 (1.8)

Irvingia Gabonensis: p = 0.012, Wilcoxon (Mann-Whitney)
Placebo: p = 0.391, Wilcoxon (Mann-Whitney)

Primary outcome: High Density Lipoprotein (HDL-C) Levels at Week 12

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	Irvingia Gabonensis n = 12	Placebo n = 12
Value	1.9 (0.4)	1.5 (0.2)

Irvingia Gabonensis: p = 0.206, Wilcoxon (Mann-Whitney)
Placebo: p = 0.721, Wilcoxon (Mann-Whitney)

Primary outcome: Systolic Blood Pressure at Week 12

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	Irvingia Gabonensis n = 12	Placebo n = 12
Value	123.5 (10.6)	126.5 (12.1)

Irvingia Gabonensis: p = 0.371, Wilcoxon (Mann-Whitney)
Placebo: p = 0.238, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the 12 weeks of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Irvingia Gabonensis	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Placebo	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metabolic Syndrome X

Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
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Enrolling by invitationEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MANUEL GONZALEZ, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Irvingia gabonensis in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Glucose Levels at Week 12 (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02354339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.