Clinical trial NCT00748787: Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metabolic Syndrome
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in the body weight
timeFrame: 16 weeks
measure: Change in the lipid profile
timeFrame: 16 weeks
measure: Change in the insulin resistance measured by HOMA index
timeFrame: 16 weeks
measure: Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin
timeFrame: 16 weeks
measure: Changes in blood pressure
timeFrame: 16 weeks
measure: Tolerability of the treatment
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari San Joan de Reus
state: Tarragona
Study officials:
affiliation: Hospital Universitari San Joan de Reus (Tarragona)
name: Jordi Salas, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria)
name: Luis Peña, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valladolid
name: Margarita Alonso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona)
name: Sergio Pinillos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Germans Trias i Pujol ( Badalona)
name: Joan Bel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Clínico Universitario de Zaragoza
name: Gloria Bueno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Univ. de Santiago de Compostela
name: Rosaura Leis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. del Niño Jesús (Madrid)
name: Teresa Muñoz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. San Joan de Reus (Tarragona)
name: Albert Feliu, MD PhD
role: PRINCIPAL_INVESTIGATOR
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