NCT01562080

Brief Summary

The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

March 21, 2012

Last Update Submit

February 27, 2013

Conditions

HyperlipidemiaLow-density-lipoprotein-typeElevated Triglycerides

Keywords

hyperlipidemiametabolic syndromeyeast redberberinepolicosanolastaxanthin

Outcome Measures

Primary Outcomes (1)

  • investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.

    twelve weeks

Secondary Outcomes (3)

  • Cardiovascular risk (according to the Framingham tables).

    twelve weeks

  • Criteria for Metabolic Syndrome

    twelve weeks

  • Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).

    twelve weeks

Study Arms (2)

Dietary supplement

EXPERIMENTAL

red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid

Dietary Supplement: Armolipid Plus

microcrystalline cellulose

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

Armolipid PlusDIETARY_SUPPLEMENT

one tablet per day during 12 weeks

Dietary supplement
placeboDIETARY_SUPPLEMENT

one tablet per day during 12 weeks

microcrystalline cellulose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 18 years old
  • 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.

You may not qualify if:

  • Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hosp. Universitario San Joan

Reus, Tarragona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25084280DERIVED

MeSH Terms

Conditions

HyperlipidemiasHypertriglyceridemiaMetabolic Syndrome

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Rosa Solà, MD PhD

    Hosp. Universitari Sant Joan de Reus (Tarragona)

    STUDY DIRECTOR

  • Jesús Millán, MD PhD

    Hosp. Universitario Gregorio Marañón (Madrid)

    PRINCIPAL INVESTIGATOR

  • José R Calabuig, MD PhD

    Hosp. Universitario La Fe (Valencia)

    PRINCIPAL INVESTIGATOR

  • José Villar, MD PhD

    Hosp. Universitario Virgen del Rocío (Sevilla)

    PRINCIPAL INVESTIGATOR

  • José Puzo, MD PhD

    Hosp. Universitario San Jorge (Huesca)

    PRINCIPAL INVESTIGATOR

  • Angel Brea, MD

    Hosp. Universitario San Pedro ( Logroño)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

ES(1)