NCT00748787

Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents

Multicenter, Double Blind, Randomized, Controlled With Placebo, to Evaluate the Effect of the Treatment With Plantago Ovata Husk in the Incidence of the Remission of Metabolic Syndrome in Children and Adolescents Between 10 to 16 Years Old.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The metabolic syndrome represents a constellation of risk factors associated to the abdominal obesity that includes insulin resistance, lipids alterations, high blood pressure etc. Several studies support the hypothesis that the intake of soluble fiber might have a positive effect in the improvement of such of these risk factors. So that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission of metabolic syndrome in children between 10 to 16 years old.

Detailed description

The prevalence of the metabolic syndrome is increasing in the last decade as well in adult people as in children and adolescents. The early diagnosis and treatment measures could be very important in order to reduce the cardiovascular risk in such populations. Ispaghula husk could be efficacious to reach the remission of the syndrome due to its effects in several important lipidic parameters. The study will consist in the treatment with Ispaghula husk during 4 months in patients with metabolic syndrome. The main variable is the remission of the metabolic syndrome following the IDF(International Diabetes Federation) criteria specifics for children.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Ispaghula husk	1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.
DRUG	Placebo	1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-11-01
• Completion: 2010-06-01
• First posted: 2008-09-09
• Last updated: 2011-06-08

Locations

1 site across 1 country: Spain