Conditions: Metabolic Syndrome X
Keywords: Metabolic syndrome central obesity Banaba insulin secretion insulin sensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

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.

Arms:
arm 1: Banaba capsules, 500mg, two times per day before meals during 90 days arm 2: Calcined magnesia capsules, 500mg, two times per day before meals during 90 days

Interventions: intervention 1: Banaba intervention 2: placebo
Intervention descriptions: intervention 1: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. intervention 2: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Protocol document: