- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748787
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tarragona
-
Reus, Tarragona, Spain, 43201
- Hospital Universitari San Joan de Reus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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:
|
Placebo Comparator: 2
|
1 sachet of effervescent powder b.i.d.
during 16 weeks, oral route.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the body weight
Time Frame: 16 weeks
|
16 weeks
|
Change in the lipid profile
Time Frame: 16 weeks
|
16 weeks
|
Change in the insulin resistance measured by HOMA index
Time Frame: 16 weeks
|
16 weeks
|
Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin
Time Frame: 16 weeks
|
16 weeks
|
Changes in blood pressure
Time Frame: 16 weeks
|
16 weeks
|
Tolerability of the treatment
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jordi Salas, MD, PhD, Hospital Universitari San Joan de Reus (Tarragona)
- Principal Investigator: 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)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAN-EC-PEDIA-01
- EudraCT number. 2007-005019-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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