Evidence map›Paper›PMID 28704936›Full record

Trial reportInternational journal of molecular sciences2017

Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study.

Valentina Spigoni, Raffaella Aldigeri, Monica Antonini, Maria Maddalena Micheli, Federica Fantuzzi, Andrea Fratter, Marzia Pellizzato, Eleonora Derlindati, Ivana Zavaroni, Riccardo C Bonadonna and 1 more

Open access · goldFull text readRandomized Controlled Trial
In one paragraph

Trial report in International journal of molecular sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 3% of its field
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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
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  7. Review
  8. Article
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  11. Article
  12. Therapeutic potential of herbal medicine for the management of hyperlipidemia: latest updates.Environmental science and pollution research international · 2022
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Phytopharmacology and Clinical Updates ofFrontiers in pharmacology · 2020
    Review
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

11 authors at 2 institutions in 1 country.

Valentina SpigoniDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. valentina.spigoni@unipr.it.
Raffaella AldigeriDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. raffaella.aldigeri@unipr.it.
Monica AntoniniDivision of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy. monypenny1975@libero.it.
Maria Maddalena MicheliDivision of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy. maddi.michi@alice.it.
Federica FantuzziDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. federica.fantuzzi@studenti.unipr.it.
Andrea FratterNutraceutical Research and Innovation Technology, Labomar Research, Istrana, 31036 Treviso, Italy. andrea.fratter@labomar.com.
Marzia PellizzatoNutraceutical Formulation, Labomar Research, Istrana, 31036 Treviso, Italy. marzia.pellizzato@labomar.com.
Eleonora DerlindatiDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. eleonora.derlindati@unipr.it.
Ivana ZavaroniDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. ivana.zavaroni@unipr.it.
Riccardo C BonadonnaDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. riccardo.bonadonna@unipr.it.
Alessandra Dei CasDepartment of Medicine and Surgery, University of Parma, 43126 Parma, Italy. alessandra.deicas@unipr.it.
University of Parma · ITOspedale di Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m²) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (-30 ± 20 mg/dL;

Indexed as

AdultAgedBerberineBiological ProductsChitosanCholesterolDrug CompoundingDyslipidemiasFemaleHumansMaleMiddle AgedProprotein Convertase 9BerberineBiological ProductsChitosanCholesterolPCSK9 protein, humanProprotein Convertase 9red yeast ricenon-HDL cholesterolnutraceuticalsPCSK9randomized clinical trial

Identifiers

PMID28704936
PMCPMC5535988
OpenAlexW2735448529

What OpenQuestion holds

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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.