N/A N=24 Randomized Double-blind Treatment

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

Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT02354339 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Fasting Glucose Levels at Week 12 — 5.7; 5.9 mmol/L — p=0.240

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Irvingia gabonensis (Dietary_supplement); Placebo (Other)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Glucose Levels at Week 12	5.7; 5.9	0.240
PRIMARY Triglycerides Levels at Week 12	2.0; 2.4	0.012 sig
PRIMARY High Density Lipoprotein (HDL-C) Levels at Week 12	1.9; 1.5	0.206
PRIMARY Systolic Blood Pressure at Week 12	123.5; 126.5	0.371
PRIMARY Diastolic Blood Pressure at Week 12.	77.5; 81.1	0.452
PRIMARY Waist Circumference at Week 12	91.1; 97.3	0.005 sig
PRIMARY First Phase of Insulin Secretion at Week 12	1382; 1690	0.791
PRIMARY Total Insulin Secretion at Week 12	0.57; 0.8	0.458
PRIMARY Total Insulin Sensitivity at Week 12	3.5; 1.9	0.470
SECONDARY Body Weight at Week 12	80.5; 79.0	0.604
SECONDARY Body Mass Index at Week 12	32.0; 31.4	0.727
SECONDARY Total Cholesterol at Week 12	5.8; 5.5	0.151
SECONDARY Low Density Lipoproteins (LDL-C) at Week 12	3.2; 2.8	0.350
SECONDARY Aspartate Aminotransferase at Week 12	27.5; 27.8	0.910
SECONDARY Alanine Aminotransferase at Week 12	27.3; 31.9	0.989
SECONDARY Creatinine at Week 12	61.9; 70.7	0.095
SECONDARY Uric Acid at Week 12	345.0; 404.5	0.910

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02354339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.