Metabolic Syndrome Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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