NCT02767869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

January 14, 2021

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

May 6, 2016

Results QC Date

August 17, 2020

Last Update Submit

December 25, 2020

Conditions

Metabolic Syndrome X

Keywords

Metabolic syndromecentral obesityBanabainsulin secretioninsulin sensitivity

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (4)

  • Weight at Week 12

    Week 12

  • Body Mass Index at Week 12

    Week 12

  • Total Cholesterol at Week 12

    Week 12

  • Low-density Lipoprotein-cholesterol (LDL-C) at Week 12

    Week 12

Study Arms (2)

Banaba

EXPERIMENTAL

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

Drug: Banaba

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

BanabaDRUG

Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.

Also known as: Lagerstroemia speciosa
Banaba
placeboDRUG

Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Also known as: calcined magnesia
Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guadalajara, Jalisco, 45037, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 34726501DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesity, AbdominalInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Manuel González Ortiz
Organization
Institute of Experimental andl Clinical Therapeutics
uiec@prodigy.net.mx
+52-33-10-58-52-00

Study Officials

  • MANUEL GONZALEZ, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

January 14, 2021

Results First Posted

October 20, 2020

Record last verified: 2020-12

Locations

ME(1)