Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-04 @ 1:57 PM
Study NCT ID:
NCT02767869
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Sponsor:
University of Guadalajara
Organization:
Study Overview
Official Title:
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: