Combined Effects of Bioactive Compounds in Lipid Profile
NCT ID: NCT01562080
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
118 participants
INTERVENTIONAL
2012-01-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dietary supplement
red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
Armolipid Plus
one tablet per day during 12 weeks
microcrystalline cellulose
placebo
one tablet per day during 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Armolipid Plus
one tablet per day during 12 weeks
placebo
one tablet per day during 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
* Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
* Signed and dated informed consent before any study specific procedure.
Exclusion Criteria
* History of cardiovascular disease, stroke or intermittent claudication.
* Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
* Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
* Plasma levels of triglycerides \> 350 mg/dl
* Diagnosis of familial hypercholesterolemia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro Tecnológico de Nutrición y Salud
OTHER
Rottapharm Spain
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rosa Solà, MD PhD
Role: STUDY_DIRECTOR
Hosp. Universitari Sant Joan de Reus (Tarragona)
Jesús Millán, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hosp. Universitario Gregorio Marañón (Madrid)
José R Calabuig, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hosp. Universitario La Fe (Valencia)
José Villar, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hosp. Universitario Virgen del Rocío (Sevilla)
José Puzo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hosp. Universitario San Jorge (Huesca)
Angel Brea, MD
Role: PRINCIPAL_INVESTIGATOR
Hosp. Universitario San Pedro ( Logroño)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hosp. Universitario San Joan
Reus, Tarragona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARM-PLUS-LDL
Identifier Type: -
Identifier Source: org_study_id