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

Primary Purpose

Metabolic Syndrome

Status

Terminated

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Ispaghula husk

Placebo

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitari San Joan de Reus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in the body weight

Change in the lipid profile

Change in the insulin resistance measured by HOMA index

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

Changes in blood pressure

Tolerability of the treatment

Full Information

NCT ID

NCT00748787

First Posted

September 8, 2008

Last Updated

June 7, 2011

Sponsor

Rottapharm Spain

1. Study Identification

Unique Protocol Identification Number

NCT00748787

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Terminated

Why Stopped

It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rottapharm Spain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ispaghula husk

Other Intervention Name(s)

Plantaben

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Change in the body weight

Time Frame

16 weeks

Title

Change in the lipid profile

Time Frame

16 weeks

Title

Change in the insulin resistance measured by HOMA index

Time Frame

16 weeks

Title

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

Time Frame

16 weeks

Title

Changes in blood pressure

Time Frame

16 weeks

Title

Tolerability of the treatment

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: