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

Phase 2TerminatedNCT00748787

Rottapharm Spain19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Ispaghula huskDRUG

1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.

PlaceboDRUG

1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari San Joan de Reus

Reus, Tarragona, Spain

Outcomes

Primary Outcomes

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 Outcomes

Change in the body weight

Time frame: 16 weeks

Change in the lipid profile

Time frame: 16 weeks

Change in the insulin resistance measured by HOMA index

Time frame: 16 weeks

Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin

Time frame: 16 weeks

Changes in blood pressure

Time frame: 16 weeks

Tolerability of the treatment

Time frame: 16 weeks

Data from ClinicalTrials.gov

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