Evidence map›Paper›PMID 32631422›Full record

ArticleTrials2020

Effects of a novel nutraceutical combination (BruMeChol™) in subjects with mild hypercholesterolemia: study protocol of a randomized, double-blind, controlled trial.

Anna Rita Bonfigli, Olga Protic, Fabiola Olivieri, Alberto Montesanto, Gelsomina Malatesta, Raffaele Di Pillo, Roberto Antonicelli

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
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  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Anna Rita BonfigliScientific Direction, IRCCS INRCA, Ancona, Italy.
Olga ProticCardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy. o.protic@inrca.it.ORCID http://orcid.org/0000-0002-1936-6139
Fabiola OlivieriDepartment of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona, Italy.
Alberto MontesantoDepartment of Biology, Ecology and Earth Sciences, University of Calabria, Rende, Italy.
Gelsomina MalatestaCardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.
Raffaele Di PilloCardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.
Roberto AntonicelliCardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.

Funding

Regione Marche POR MARCHE FESR 2014-2020 project PrInT AGE 10439
6 · The paper itself

Abstract

backgroundElevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering and inflammation-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. Here, we describe the study protocol of a clinical trial aimed to evaluate the cholesterol and inflammatory lowering effect of an innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits in association with vitamin K2 in subjects with mild hypercholesterolemia.

methodsThe study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age ≥ 40 years) with mild hypercholesterolemia (total serum cholesterol levels ≥ 200 and ≤ 250 mg/dl) will be recruited. Intervention arm participants will take one capsule of dietary supplement two times a day, 15 min before the main meal. Control arm participants will receive one capsule of placebo in the same way. The dietary supplement capsule contains the following ingredients: phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2. Participants will undergo a medical evaluation and chemical-clinical examinations, which include lipid profile, glycemia, biomarkers of renal, liver and cardiac/muscular functions, interleukins (IL 6, IL-32, IL-37, and IL-38), and innovative mediators of inflammation such as inflamma-miRs (miR-21 and miR-146a), at baseline, and after 6 and 12 weeks of treatment. The decrease in total cholesterol levels and inflammatory biomarkers will be the primary and secondary endpoints of the study. DISCUSSION: This protocol study, planned to verify the effects of BruMeChol™ dietary supplementation in subjects with mild hypercholesterolemia, could also contribute to new study designs for next large-scale multicenter clinical trials.

trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12619000170123 . Retrospectively registered on 5 February 2019.

Indexed as

Dietary SupplementsBiomarkersCardiovascular DiseasesDouble-Blind MethodDrug CombinationsHumansHypercholesterolemiaItalyLipidsRandomized Controlled Trials as TopicRisk FactorsBiomarkersDrug CombinationsLipidsBergamot fruitCardiovascular diseasesDietary supplementsHypercholesterolemiaOlive oilPhytosterolsRandomized controlled trialVitamin K2

Identifiers

PMID32631422
PMCPMC7336431

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.