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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748787
Recruitment Status : Terminated (It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.)
First Posted : September 9, 2008
Last Update Posted : June 8, 2011
Information provided by:
Rottapharm Spain

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Ispaghula husk Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : October 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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 Name: Plantaben

Placebo Comparator: 2 Drug: Placebo
1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in the body weight [ Time Frame: 16 weeks ]
  2. Change in the lipid profile [ Time Frame: 16 weeks ]
  3. Change in the insulin resistance measured by HOMA index [ Time Frame: 16 weeks ]
  4. Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin [ Time Frame: 16 weeks ]
  5. Changes in blood pressure [ Time Frame: 16 weeks ]
  6. Tolerability of the treatment [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748787

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Hospital Universitari San Joan de Reus
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
Rottapharm Spain
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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)
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Responsible Party: Anna Anguera, Research Manager Identifier: NCT00748787    
Other Study ID Numbers: PLAN-EC-PEDIA-01
EudraCT number. 2007-005019-25
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Calcium polycarbophil
Gastrointestinal Agents