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

This study has been terminated.
(It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.)
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00748787
First received: September 8, 2008
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Drug: Ispaghula husk
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • 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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in the lipid profile [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in the insulin resistance measured by HOMA index [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Changes in blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Tolerability of the treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Plantaben
Placebo Comparator: 2 Drug: Placebo
1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.

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

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748787

Locations
Spain
Hospital Universitari San Joan de Reus
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
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)
  More Information

No publications provided

Responsible Party: Anna Anguera, Research Manager
ClinicalTrials.gov Identifier: NCT00748787     History of Changes
Other Study ID Numbers: PLAN-EC-PEDIA-01, EudraCT number. 2007-005019-25
Study First Received: September 8, 2008
Last Updated: June 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on August 28, 2014