Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents
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 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.|
- 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 ]
- 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 ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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||
1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.
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.
|Hospital Universitari San Joan de Reus|
|Reus, Tarragona, Spain, 43201|
|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)|