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

Phase 2

Terminated

• Conditions: Metabolic Syndrome
• Interventions: Drug: Ispaghula husk; Drug: Placebo

• Registration Number: NCT00748787
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Study Start: 2008-10
• Primary Completion: 2009-11
• Study Completion: 2010-06
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ispaghula husk	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitari San Joan de Reus; 🇪🇸 Reus, Tarragona, Spain