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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Ispaghula husk
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria: Waist circumference > or equal to percentile 90 according the age. 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 Cholesterol HDL < 1.03 mmol/l or treatment with drugs to increase cHDL 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Ispaghula husk<br>* 1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.<br>* Other names: Plantaben;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the body weight |  | 16 weeks | 
| Change in the lipid profile |  | 16 weeks | 
| Change in the insulin resistance measured by HOMA index |  | 16 weeks | 
| Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin |  | 16 weeks | 
| Changes in blood pressure |  | 16 weeks | 
| Tolerability of the treatment |  | 16 weeks |