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

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748787
• Other study ID #: PLAN-EC-PEDIA-01
• Secondary ID: EudraCT number.
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2008
• Last updated: June 7, 2011
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari San Joan de Reus	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in the body weight		16 weeks	No
Secondary	Change in the lipid profile		16 weeks	No
Secondary	Change in the insulin resistance measured by HOMA index		16 weeks	No
Secondary	Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin		16 weeks	No
Secondary	Changes in blood pressure		16 weeks	No
Secondary	Tolerability of the treatment		16 weeks	Yes