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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rottapharm Spain
• Treatments: Calcium polycarbophil; Psyllium

Criteria

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.