Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Drug: Banaba; Drug: placebo

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.

12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

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

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45037
      • Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients both sexes,
• Age between 30 and 60 years,
• Metabolic Syndrome according to the IDF criteria
• Waist circumference
• Man ≥90 cm
• Woman ≥80 cm

And two of the following criteria:

• High density lipoprotein
• Man ≤40 mg/dL
• Woman ≤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
• Hypersensibility to resveratrol
• Physical impossibility for taking pills
• Known uncontrolled renal, hepatic, heart or thyroid diseased
• 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
• Low density lipoprotein (c-LDL) ≥190 mg/dL
• Blood Pressure ≥140/90 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Banaba; Banaba capsules, 500mg, two times per day before meals during 90 days	Drug: Banaba; Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.; Other Names: Lagerstroemia speciosa
Placebo Comparator: Placebo; Calcined magnesia capsules, 500mg, two times per day before meals during 90 days	Drug: placebo; Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg; Other Names: calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride Levels at Week 12	The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.	Week 12
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12	The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.	Week 12
Fasting Glucose Levels at Week 12	The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12	Week 12
Systolic Blood Pressure at Week 12.	The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12	Week 12
First Phase of Insulin Secretion at Week 12	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 frst phase of insulin secretion at week 12.	Week 12
Total Insulin Secretion at Week 12.	Measure Description: 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 (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.	Week 12
Total Insulin Sensitivity at Week 12	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 at week 12.	Week 12
Waist Circumference at Week 12	Waist circumference will be evaluated at baseline and at week 12 with a flexible tape	Week 12
Diastolic Blood Pressure at Week 12	The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight at Week 12	The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12	Week 12
Body Mass Index at Week 12	The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12	Week 12
Total Cholesterol at Week 12	The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12	Week 12
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12	The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12	Week 12

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lopez-Murillo LD, Gonzalez-Ortiz M, Martinez-Abundis E, Cortez-Navarrete M, Perez-Rubio KG. Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2022 Feb;25(2):177-182. doi: 10.1089/jmf.2021.0039. Epub 2021 Nov 2.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: December 25, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Metabolic syndrome; insulin sensitivity; insulin secretion; central obesity; Banaba
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Disease; Hyperinsulinism; Hypersensitivity; Syndrome; Metabolic Syndrome; Insulin Resistance; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Magnesium Oxide
• Other Study ID Numbers: BANABA-MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No