HypercholesterolemiaPhase 2/3NCT00502047
Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
A Phase 2/3 study testing Plantago ovata husk in people with Hypercholesterolemia and Cardiovascular Disease, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Disease
- What is being tested?
- Plantago ovata husk
- How many people
- 255 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Levels of LDL-c between >130 mg/dl and <189 mg/dl
- Presence at least 1 of the cardiovascular risk factor defined as:
- age above 45 years in men and 55 years in women
- smoker
- high blood pressure
- HDL-c < 40 mg/dl in men and <46 mg/dl in women
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- family background of early heart disease
- Patients who have given informed consent
- Patients who will be capable of following diet guidelines
Who cannot join
- Triglycerides >350 mg/dl
- History of cardiovascular disease
- treatment with statins prior to the beginning of the trial and who have not dropped out at least 2 months before the beginning of the study
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hosp. Universitario San Joan de Reus, (Spain)
Reus, Tarragona, 43201
About this study
Official title: Multicentre, Comparative, Double-Blind, Two-Arm Parallel Clinical Trial of the Effects of Treatment With Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors.
Read the detailed description
It has been demonstrated that high concentrations of cholesterol and low density lipoprotein cholesterol (LDL, high risk cholesterol) are the major risk factors for heart disease, myocardial infarction and angina pectoris. Moreover, these conditions represent the major cause of death in the Western world.
Of the measures established to reduce blood cholesterol levels, the introduction of consumption of dietary fibre is a novelty. The term dietary fibre defines a variety of substances that are found in plants and are resistant to digestion by human gastrointestinal enzymes.
The studies performed up until now to determine the effects of fibre on blood lipids have demonstrated that consumption of soluble fibre can reduce cholesterol.
- Conditions
- Hypercholesterolemia, Cardiovascular Disease
- Being tested
- Plantago ovata husk
- Keywords
- plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantago ovata huskDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia.
Measured: 16 weeks
Secondary outcomes (3)
To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective
Measured: 16 weeks
To analyse the effect of Plantago ovata husk fibre on blood pressure
Measured: 16 weeks
To evaluate whether the response on plasma lipids is modulated by the polymorphisms of apolipoprotein E, cholesterol ester transfer protein (CETP), apolipoprotein A-V and Fatty acid binding protein 2 (FABP2)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rosa Solà, MD, phD, Study chair, Hosp. Universitario San Joan de Reus , SpainManuel Castro, MD, phD, Principal investigator, Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)Eric Brucker, MD, phD, Principal investigator, Hosp. de la Pitié, Paris (France)Mª Cruz Almaraz, MD, Principal investigator, Hosp. Universitario Carlos Haya, Málaga (Spain)Xavier Luque, MD, Principal investigator, Centro de Atención Primaria Alcover, Tarragona (Spain)José Vicente Vaquer, MD, Principal investigator, Centro de Salud Petrer I, Alicante (Spain)Luis de Teresa, MD, Principal investigator, Hosp. San Vicente de Raspeig, Alicante (Spain)Silvia Narejos, MD, Principal investigator, Centro de Atención Primaria Centelles, Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502047
- Sponsor's protocol ID
- PLAN-EC-HIPERL-02
- Other IDs
- EudraCT number: 2004-002184-24
- Status last verified
- Jul 2007
- First submitted
- 16 Jul 2007
- Last updated
- 17 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.
PubMed 23840361
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Comparative, Double-Blind, Two-Arm Parallel Clinical Trial of the Effects of Treatment With Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00502047
- Acronym / sponsor ID
- PLAN-EC-HIPERL-02
- Conditions
- Hypercholesterolemia, Cardiovascular Disease
- Keywords
- plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Jul 2007 (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.
The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors.
Detailed description
It has been demonstrated that high concentrations of cholesterol and low density lipoprotein cholesterol (LDL, high risk cholesterol) are the major risk factors for heart disease, myocardial infarction and angina pectoris. Moreover, these conditions represent the major cause of death in the Western world.
Of the measures established to reduce blood cholesterol levels, the introduction of consumption of dietary fibre is a novelty. The term dietary fibre defines a variety of substances that are found in plants and are resistant to digestion by human gastrointestinal enzymes.
The studies performed up until now to determine the effects of fibre on blood lipids have demonstrated that consumption of soluble fibre can reduce cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Levels of LDL-c between >130 mg/dl and <189 mg/dl
- Presence at least 1 of the cardiovascular risk factor defined as:
- age above 45 years in men and 55 years in women
- smoker
- high blood pressure
Key exclusion criteria (4 listed)
- Triglycerides >350 mg/dl
- History of cardiovascular disease
- Diabetes mellitus
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 |
|---|---|---|
| Plantago ovata husk | Drug | – |
Primary outcome
To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia.
Time frame: 16 weeks
3 secondary outcomes
To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective
Time frame: 16 weeks
To analyse the effect of Plantago ovata husk fibre on blood pressure
Time frame: 16 weeks
To evaluate whether the response on plasma lipids is modulated by the polymorphisms of apolipoprotein E, cholesterol ester transfer protein (CETP), apolipoprotein A-V and Fatty acid binding protein 2 (FABP2)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2007.
- Derived from this study: PubMed 23840361Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.
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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.
Rosa Solà, MD, phD study chair
Hosp. Universitario San Joan de Reus , Spain
Manuel Castro, MD, phD principal investigator
Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)
Eric Brucker, MD, phD principal investigator
Hosp. de la Pitié, Paris (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Plantago ovata husk in people with Hypercholesterolemia and Cardiovascular Disease, 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jul 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia. (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 NCT00502047, which also lists 1 linked publication.
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 17 Jul 2007.