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

NCT00748787 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

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.

Sponsors & Collaborators

  • Rottapharm Spain

    lead INDUSTRY

Principal Investigators

  • Jordi Salas, MD, PhD · Hospital Universitari San Joan de Reus (Tarragona)

  • Luis Peña, MD, PhD · Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria)

  • Margarita Alonso, MD, PhD · Hospital Universitario de Valladolid

  • Sergio Pinillos, MD · Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona)

  • Joan Bel, MD, PhD · Hospital Universitari Germans Trias i Pujol ( Badalona)

  • Gloria Bueno, MD, PhD · Hosp. Clínico Universitario de Zaragoza

  • Rosaura Leis, MD, PhD · Hospital Clínico Univ. de Santiago de Compostela

  • Teresa Muñoz, MD, PhD · Hospital Univ. del Niño Jesús (Madrid)

  • Albert Feliu, MD PhD · Hospital Univ. San Joan de Reus (Tarragona)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-11-30
Completion
2010-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748787 on ClinicalTrials.gov