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

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Banaba
placebo
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Banaba

Placebo

Arm Description

Banaba capsules, 500mg, two times per day before meals during 90 days

Calcined magnesia capsules, 500mg, two times per day before meals during 90 days

Outcomes

Primary Outcome Measures

Triglyceride Levels at Week 12
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
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
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
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.
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.
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.
Waist Circumference at Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 6, 2016
Last Updated
December 25, 2020
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT02767869
Brief Title
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Official Title
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Banaba
Arm Type
Experimental
Arm Description
Banaba capsules, 500mg, two times per day before meals during 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
Intervention Type
Drug
Intervention Name(s)
Banaba
Other Intervention Name(s)
Lagerstroemia speciosa
Intervention Description
Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
calcined magnesia
Intervention Description
Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
Primary Outcome Measure Information:
Title
Triglyceride Levels at Week 12
Description
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
Time Frame
Week 12
Title
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
Description
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
Time Frame
Week 12
Title
Fasting Glucose Levels at Week 12
Description
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
Time Frame
Week 12
Title
Systolic Blood Pressure at Week 12.
Description
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
Time Frame
Week 12
Title
First Phase of Insulin Secretion at Week 12
Description
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.
Time Frame
Week 12
Title
Total Insulin Secretion at Week 12.
Description
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.
Time Frame
Week 12
Title
Total Insulin Sensitivity at Week 12
Description
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.
Time Frame
Week 12
Title
Waist Circumference at Week 12
Description
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
Time Frame
Week 12
Title
Diastolic Blood Pressure at Week 12
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Weight at Week 12
Description
The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Time Frame
Week 12
Title
Body Mass Index at Week 12
Description
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
Time Frame
Week 12
Title
Total Cholesterol at Week 12
Description
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
Time Frame
Week 12
Title
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12
Description
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
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MANUEL GONZALEZ, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45037
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
34726501
Citation
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.
Results Reference
derived

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

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