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.

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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: Ispaghula husk; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43201
      • Hospital Universitari San Joan de Reus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:

  1. Waist circumference > or equal to percentile 90 according the age.
  2. Presence of 2 or more of following factors: systolic blood pressure > or equal 130 mmHg or diastolic > or equal to 85 mmHg, or treated hypertension
  3. Cholesterol HDL < 1.03 mmol/l or treatment with drugs to increase cHDL
  4. Glucose blood levels > 5.6 mmol/l or type II diabetes diagnosed treated or no.

Exclusion Criteria:

• Loss of body weight > 3kg in the last 2 months
• Waist circumference 10 cm higher of 90 percentile according to the age
• Intake of fiber, aven supplements or phytosterols in the last 2 months
• Glycosylate haemoglobin >7% in the time of inclusion
• Systolic blood pressure > 145 mmHg or Diastolic blood pressure >95 mmHg.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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.; Other Names: Plantaben
Placebo Comparator: 2	Drug: Placebo; 1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Remission of the metabolic syndrome following the IDF criteria for children, it means, waist circumference lower than 90 percentile of the population according to the age.	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the body weight	16 weeks
Change in the lipid profile	16 weeks
Change in the insulin resistance measured by HOMA index	16 weeks
Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin	16 weeks
Changes in blood pressure	16 weeks
Tolerability of the treatment	16 weeks

Collaborators and Investigators

• Sponsor: Rottapharm Spain
• Investigators: Study Chair: Jordi Salas, MD, PhD, Hospital Universitari San Joan de Reus (Tarragona); Principal Investigator: Luis Peña, MD, PhD, Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria); Principal Investigator: Margarita Alonso, MD, PhD, Hospital Universitario de Valladolid; Principal Investigator: Sergio Pinillos, MD, Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona); Principal Investigator: Joan Bel, MD, PhD, Hospital Universitari Germans Trias i Pujol ( Badalona); Principal Investigator: Gloria Bueno, MD, PhD, Hosp. Clínico Universitario de Zaragoza; Principal Investigator: Rosaura Leis, MD, PhD, Hospital Clínico Univ. de Santiago de Compostela; Principal Investigator: Teresa Muñoz, MD, PhD, Hospital Univ. del Niño Jesús (Madrid); Principal Investigator: Albert Feliu, MD PhD, Hospital Univ. San Joan de Reus (Tarragona)

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Gastrointestinal Agents; Cathartics; Antidiarrheals; Psyllium; Calcium polycarbophil
• Other Study ID Numbers: PLAN-EC-PEDIA-01; EudraCT number. 2007-005019-25