Trial | NCT00748787  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    19
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 Started
Oct 31
2008
Primary Completion
Nov 30
2009
Study Completion
Jun 30
2010
Last Update
Jun 08
2011
Estimate

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.

  • Other names: Plantaben

Drug Placebo

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

1 Experimental

2 Placebo Comparator

Criteria 

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.
No Results Posted