NCT00748787

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

September 8, 2008

Last Update Submit

June 7, 2011

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Ispaghula husk

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Ispaghula huskDRUG

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

Also known as: Plantaben
1
PlaceboDRUG

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

2

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Systolic blood pressure \> 145 mmHg or Diastolic blood pressure \>95 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari San Joan de Reus

Reus, Tarragona, 43201, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

ispaghula seed

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jordi Salas, MD, PhD

    Hospital Universitari San Joan de Reus (Tarragona)

    STUDY CHAIR

  • Luis Peña, MD, PhD

    Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria)

    PRINCIPAL INVESTIGATOR

  • Margarita Alonso, MD, PhD

    Hospital Universitario de Valladolid

    PRINCIPAL INVESTIGATOR

  • Sergio Pinillos, MD

    Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona)

    PRINCIPAL INVESTIGATOR

  • Joan Bel, MD, PhD

    Hospital Universitari Germans Trias i Pujol ( Badalona)

    PRINCIPAL INVESTIGATOR

  • Gloria Bueno, MD, PhD

    Hosp. Clínico Universitario de Zaragoza

    PRINCIPAL INVESTIGATOR

  • Rosaura Leis, MD, PhD

    Hospital Clínico Univ. de Santiago de Compostela

    PRINCIPAL INVESTIGATOR

  • Teresa Muñoz, MD, PhD

    Hospital Univ. del Niño Jesús (Madrid)

    PRINCIPAL INVESTIGATOR

  • Albert Feliu, MD PhD

    Hospital Univ. San Joan de Reus (Tarragona)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

ES(1)