Phase 2 N=24 Randomized Double-blind Treatment

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

Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT02767869 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Triglyceride Levels at Week 12 — 148.0; 199.9 mg/dL — p=0.021

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Banaba (Drug); placebo (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Triglyceride Levels at Week 12	148.0; 199.9	0.021 sig
PRIMARY High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12	56.4; 58.4	0.530
PRIMARY Fasting Glucose Levels at Week 12	103.2; 104.2	0.034 sig
PRIMARY Systolic Blood Pressure at Week 12.	116.3; 122.6	0.050
PRIMARY First Phase of Insulin Secretion at Week 12	913.9; 651.0	0.799
PRIMARY Total Insulin Secretion at Week 12.	0.3; 0.3	0.047 sig
PRIMARY Total Insulin Sensitivity at Week 12	5.1; 5.5	0.878
PRIMARY Waist Circumference at Week 12	95.7; 97.0	0.919
PRIMARY Diastolic Blood Pressure at Week 12	72.5; 76.5	0.254
SECONDARY Weight at Week 12	72.6; 72.2	0.347
SECONDARY Body Mass Index at Week 12	28.4; 28.9	0.227
SECONDARY Total Cholesterol at Week 12	210.0; 201.7	0.410
SECONDARY Low-density Lipoprotein-cholesterol (LDL-C) at Week 12	29.0; 39.9	0.021 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02767869). 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.