NCT00502047

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

July 17, 2007

Status Verified

July 1, 2007

First QC Date

July 16, 2007

Last Update Submit

July 16, 2007

Conditions

HypercholesterolemiaCardiovascular Disease

Keywords

plantago ovata husksoluble fibrehypercholesterolemiacardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    16 weeks

  • To analyse the effect of Plantago ovata husk fibre on blood pressure

    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)

    16 weeks

Interventions

Plantago ovata huskDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • family background of early heart disease
  • Patients who have given informed consent
  • Patients who will be capable of following diet guidelines

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hosp. Universitario San Joan de Reus, (Spain)

Reus, Tarragona, 43201, Spain

Location

Related Publications (1)

  • 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.

    PMID: 23840361DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rosa Solà, MD, phD

    Hosp. Universitario San Joan de Reus , Spain

    STUDY CHAIR

  • Manuel Castro, MD, phD

    Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)

    PRINCIPAL INVESTIGATOR

  • Eric Brucker, MD, phD

    Hosp. de la Pitié, Paris (France)

    PRINCIPAL INVESTIGATOR

  • Mª Cruz Almaraz, MD

    Hosp. Universitario Carlos Haya, Málaga (Spain)

    PRINCIPAL INVESTIGATOR

  • Xavier Luque, MD

    Centro de Atención Primaria Alcover, Tarragona (Spain)

    PRINCIPAL INVESTIGATOR

  • José Vicente Vaquer, MD

    Centro de Salud Petrer I, Alicante (Spain)

    PRINCIPAL INVESTIGATOR

  • Luis de Teresa, MD

    Hosp. San Vicente de Raspeig, Alicante (Spain)

    PRINCIPAL INVESTIGATOR

  • Silvia Narejos, MD

    Centro de Atención Primaria Centelles, Barcelona (Spain)

    PRINCIPAL INVESTIGATOR

  • Xavier Farrés, MD

    Centro de Atención Primaria El Remei, Vic, Barcelona (Spain)

    PRINCIPAL INVESTIGATOR

  • José Miguel Martínez, MD

    Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

September 1, 2005

Study Completion

July 1, 2007

Last Updated

July 17, 2007

Record last verified: 2007-07

Locations

ES(1)