Evidence map›Paper›PMID 26797632›Full record

Trial reportNutrients2016

Probiotic Soy Product Supplemented with Isoflavones Improves the Lipid Profile of Moderately Hypercholesterolemic Men: A Randomized Controlled Trial.

Daniela Cardoso Umbelino Cavallini, Marla Simone Jovenasso Manzoni, Raquel Bedani, Mariana Nougalli Roselino, Larissa Sbaglia Celiberto, Regina Célia Vendramini, Graciela Font de Valdez, Dulcinéia Saes Parra Abdalla, Roseli Aparecida Pinto, Daniella Rosetto and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
–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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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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

12 authors.

Daniela Cardoso Umbelino CavalliniDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. cavallinidc@fcfar.unesp.br.
Marla Simone Jovenasso ManzoniDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. mamanzoni@hotmail.com.
Raquel BedaniDepartment of Biochemical and Pharmaceutical Technology, School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508900, Brazil. raquelbedani@yahoo.com.br.
Mariana Nougalli RoselinoDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. mari_roselino@yahoo.com.br.
Larissa Sbaglia CelibertoDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. larissasbaglia@gmail.com.
Regina Célia VendraminiDepartamento de Análises Clínicas, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. vendrasp@fcfar.unesp.br.
Graciela Font de ValdezReference Center for Lactobacilli, CERELA, S.M. Tucuman T4000ILC, Argentina. gfont@cerela.org.ar.
Dulcinéia Saes Parra AbdallaDepartment of Clinical and Toxicological Analyses, School of Pharmaceutical Sciences, University of Sao Paulo, São Paulo 05508900, Brazil. dspabdalla@gmail.com.
Roseli Aparecida PintoDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. rosely@fcfar.unesp.br.
Daniella RosettoDepartamento de Ciências Biológicas, Faculdade de Ciências Farmacêuticas, UNESP -Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. daniella.rossetto@gmail.com.
Sandro Roberto ValentiniDepartamento de Ciências Biológicas, Faculdade de Ciências Farmacêuticas, UNESP -Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. valentsr@fcfar.unesp.br.
Elizeu Antonio RossiDepartamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. rossiea@fcfar.unesp.br.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiovascular disease is the leading cause of worldwide morbidity and mortality. Several studies have demonstrated that specific probiotics affect the host's metabolism and may influence the cardiovascular disease risk.

objectivesThe aim of this study was to investigate the influence of an isoflavone-supplemented soy product fermented with Enterococcus faecium CRL 183 and Lactobacillus helveticus 416 on cardiovascular risk markers in moderately hypercholesterolemic subjects.

designRandomized placebo-controlled double-blind trial Setting: São Paulo State University in Araraquara, SP, Brazil.

participants49 male healthy men with total cholesterol (TC) >5.17 mmol/L and <6.21 mmol/L Intervention: The volunteers have consumed 200 mL of the probiotic soy product (group SP-10(10) CFU/day), isoflavone-supplemented probiotic soy product (group ISP-probiotic plus 50 mg of total isoflavones/100 g) or unfermented soy product (group USP-placebo) for 42 days in a randomized, double-blind study.

main outcome measuresLipid profile and additional cardiovascular biomarkers were analyzed on days 0, 30 and 42. Urine samples (24 h) were collected at baseline and at the end of the experiment so as to determine the isoflavones profile.

resultsAfter 42 days, the ISP consumption led to improved total cholesterol, non-HDL-C (LDL + IDL + VLDL cholesterol fractions) and electronegative LDL concentrations (reduction of 13.8%, 14.7% and 24.2%, respectively, p < 0.05). The ISP and SP have prevented the reduction of HDL-C level after 42 days. The C-reactive protein and fibrinogen levels were not improved. The equol production by the ISP group subjects was inversely correlated with electronegative LDL concentration.

conclusionsThe results suggest that a regular consumption of this probiotic soy product, supplemented with isoflavones, could contribute to reducing the risk of cardiovascular diseases in moderately hypercholesterolemic men, through the an improvement in lipid profile and antioxidant properties.

Indexed as

Dietary SupplementsAdultAntioxidantsBiomarkersCardiovascular DiseasesCholesterolCholesterol, HDLCholesterol, LDLDouble-Blind MethodHealthy VolunteersHumansHypercholesterolemiaIsoflavonesLipidsMaleMiddle AgedAntioxidantsBiomarkersCholesterolCholesterol, HDLCholesterol, LDLIsoflavonesLipidsEnterococcus faecium CRL183fermented soy productisoflavoneslipid profileprobiotic

Identifiers

PMID26797632
PMCPMC4728664

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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.