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

University of Guadalajara

Status and phase: Completed; Phase 2

Conditions: Metabolic Syndrome X

Treatments: Drug: placebo; Drug: Banaba

Study type: Interventional

Funder types: Other

Identifiers

NCT02767869

BANABA-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Banaba

Experimental group

Description:

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

Treatment:

Drug: Banaba

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo