Metabolic SyndromePhase 2NCT00748787

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

A Phase 2 study testing Ispaghula husk in people with Metabolic Syndrome, run by Rottapharm Spain at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 10 to 16 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Ispaghula husk
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteSpain
Study dates: Oct 2008to Jun 2010
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari San Joan de Reus
Reus, Tarragona, 43201

Other trials in Spain

About this study

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.

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.

Read the 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.

Conditions: Metabolic Syndrome
Being tested: Ispaghula husk, Placebo
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00748787
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Ispaghula husk
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 16 weeks

Secondary outcomes (6)

Change in the body weight
Measured: 16 weeks
Change in the lipid profile
Measured: 16 weeks
Change in the insulin resistance measured by HOMA index
Measured: 16 weeks
Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin
Measured: 16 weeks
Changes in blood pressure
Measured: 16 weeks
Tolerability of the treatment
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jun 2010

First posted9 Sep 2008 (estimated)
Study startOct 2008
Primary completionNov 2009
Study completionJun 2010

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00748787
Sponsor's protocol ID: PLAN-EC-PEDIA-01
Other IDs: EudraCT number. 2007-005019-25
Status last verified: Jun 2011
First submitted: 8 Sep 2008
Last updated: 8 Jun 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00748787
Acronym / sponsor ID: PLAN-EC-PEDIA-01
Conditions: Metabolic Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.
Enrolment: 19 participants (actual)
Lead sponsor: Rottapharm SpainIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Nov 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 9 Sep 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Ispaghula husk could be efficacious to reach the remission of the syndrome due to its effects in several important lipidic parameters.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Ispaghula husk
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 10 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ispaghula huskAlso: Plantaben1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.	Drug	1
Placebo1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.	Drug	2

Primary outcome

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

6 secondary outcomes

Change in the body weight
Time frame: 16 weeks
Change in the lipid profile
Time frame: 16 weeks
Change in the insulin resistance measured by HOMA index
Time frame: 16 weeks
Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin
Time frame: 16 weeks
Changes in blood pressure
Time frame: 16 weeks
Tolerability of the treatment
Time frame: 16 weeks

Results and safety

The study was stopped early (reason given: It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jordi Salas, MD, PhD study chair

Hospital Universitari San Joan de Reus (Tarragona)

Luis Peña, MD, PhD principal investigator

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

Margarita Alonso, MD, PhD principal investigator

Hospital Universitario de Valladolid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ispaghula husk in people with Metabolic Syndrome, run by Rottapharm Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00748787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.