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Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels

NCT03739242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-10-14

Study results available
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Summary

High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both, can reduce cholesterol and reduce rate of cardiovascular events. The trial will evaluate natural alternative to this drug approach testing the effects of a combination of phytosterol, a nutritional that reduce cholesterol absorption, and fermented red rice, a nutritional that reduce the synthesis of cholesterol. Subjects with sub optimal blood cholesterol levels, matching all the inclusion criteria and none of the exclusion criteria, will be treated for 8 weeks with a nutraceutical combination of phytosterols and fermented red rice and will have to maintain, during the entire duration of the study, the Mediterranean-style diet provided. The study will evaluate as primary objective the changes in LDL cholesterol blood levels and more in general the modulation of lipid profile and of others clinical parameters as well as the tolerability.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nutraceutical combination

One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

OTHER

Placebo

One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Sponsors & Collaborators

  • A. Menarini Industrie Farmaceutiche Riunite S.r.l.

    lead INDUSTRY

Principal Investigators

  • Claudio Borghi, Professor · Policlinico S.Orsola - Malpighi Medicina Interna Borghi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2018-08-29
Completion
2018-08-29

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739242 on ClinicalTrials.gov