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

NCT02354339 | Completed Results

• 1 other identifier: MS-IGABONENSIS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X

Keywords

Metabolic Syndrome; Irvingia gabonensis; African mango; Insulin resistance

Outcome Measures

Primary Outcomes (9)

• Fasting Glucose Levels at Week 12

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

  12 weeks

• Triglycerides Levels at Week 12

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

  12 weeks

• High Density Lipoprotein (HDL-C) Levels at Week 12

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

  12 weeks

• Systolic Blood Pressure at Week 12

  The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

  12 weeks

• Diastolic Blood Pressure at Week 12.

  The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

  Baseline. Week 12

• Waist Circumference at Week 12

  The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape

  12 weeks

• First Phase of Insulin Secretion at Week 12

  The first phase of insulin secretion will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion

  12 weeks

• Total Insulin Secretion at Week 12

  Total insulin secretion will be calculated at baseline and week 12 with the insulinogenic index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion

  12 weeks

• Total Insulin Sensitivity at Week 12

  Insulin sensitivity will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity

  12 weeks

Secondary Outcomes (8)

• Body Weight at Week 12

  12 weeks

• Body Mass Index at Week 12

  12 weeks

• Total Cholesterol at Week 12

  12 weeks

• Low Density Lipoproteins (LDL-C) at Week 12

  12 weeks

• Aspartate Aminotransferase at Week 12

  12 weeks

Study Arms (2)

Irvingia gabonensis

EXPERIMENTAL

Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Dietary Supplement: Irvingia gabonensis

Placebo

PLACEBO COMPARATOR

Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks

Other: Placebo

Interventions

Irvingia gabonensis DIETARY_SUPPLEMENT

Intervention will be administered 30 minutes before meals

Also known as: African mango

Irvingia gabonensis

Placebo OTHER

Intervention will be administered 30 minutes before meals

Also known as: calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

dikanut

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

uice@prodigy.net.mx

+52 3310585200

Study Officials

• MANUEL GONZALEZ, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Model Details: This is a study with two groups of patients with metabolic syndrome. One group received Irvingia Gabonensis and the other received placebo as control.

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

ME (1)