Evidence mapPaperPMID 38750102Full record

Trial reportScientific reports2024

Nutraceutical blends predict enhanced health via microbiota reshaping improving cytokines and life quality: a Brazilian double-blind randomized trial.

Aline Boveto Santamarina, Jéssica Alves de Freitas, Lucas Augusto Moyses Franco, Victor Nehmi-Filho, Joyce Vanessa Fonseca, Roberta Cristina Martins, José Antônio Turri, Bruna Fernanda Rio Branco da Silva, Beatriz Emi Itikawa Fugi, Sumaia Sobral da Fonseca and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04810572 (Evaluation of the Effects of a Nutraceutical Composition Containing Derivatives From Natural Products on the Modulation of the Endocrine Neuroimmune Axis - Translational Study.), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 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.

NCT04810572 nacompletednot on this map

Evaluation of the Effects of a Nutraceutical Composition Containing Derivatives From Natural Products on the Modulation of the Endocrine Neuroimmune Axis - Translational Study.

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2021 to 2022Enrolled162ConditionsInsulin Resistance, Inflammatory Bowel Diseases, Overweight and Obesity, HealthyArmsComposition with Silymarin, Low-mineral composition without Silymarin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Impacts of Lifestyle and Microbiota-Targeted Interventions for Overweight and Obesity on the Human Gut Microbiome: A Systematic Review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
    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

17 authors.

Aline Boveto SantamarinaLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Jéssica Alves de FreitasLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Lucas Augusto Moyses FrancoLaboratório de Parasitologia Médica (LIM-46), Departamento de Doenças Infecciosas e Parasitárias, Universidade de São Paulo Instituto de Medicina Tropical de São Paulo, São Paulo, SP, 05403-000, Brazil.
Victor Nehmi-FilhoLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Joyce Vanessa FonsecaLaboratório de Investigação Médica em Protozoologia, Bacteriologia e Resistência Antimicrobiana (LIM-49)Departamento de Doenças Infecciosas e Parasitárias, Universidade de São Paulo Instituto de Medicina Tropical de São Paulo, São Paulo, SP, 05403-000, Brazil.
Roberta Cristina MartinsLaboratório de Parasitologia Médica (LIM-46), Departamento de Doenças Infecciosas e Parasitárias, Universidade de São Paulo Instituto de Medicina Tropical de São Paulo, São Paulo, SP, 05403-000, Brazil.
José Antônio TurriGrupo de Pesquisa em Economia da Saúde, Departamento de Ginecologia e Obstetrícia, Universidade de São Paulo Faculdade de Medicina, São Paulo, SP, 01246903, Brazil.
Bruna Fernanda Rio Branco da SilvaLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Beatriz Emi Itikawa FugiLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Sumaia Sobral da FonsecaLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Arianne Fagotti GusmãoInternational Research Center, A.C. Camargo Cancer Center, São Paulo, SP, 01508-010, Brazil.
Eloísa Helena Ribeiro OlivieriInternational Research Center, A.C. Camargo Cancer Center, São Paulo, SP, 01508-010, Brazil.
Erica de SouzaAmbulatório Monte Azul, São Paulo, SP, 05801-110, Brazil.
Silvia CostaLaboratório de Investigação Médica em Protozoologia, Bacteriologia e Resistência Antimicrobiana (LIM-49)Departamento de Doenças Infecciosas e Parasitárias, Universidade de São Paulo Instituto de Medicina Tropical de São Paulo, São Paulo, SP, 05403-000, Brazil.
Ester Cerdeira SabinoLaboratório de Parasitologia Médica (LIM-46), Departamento de Doenças Infecciosas e Parasitárias, Universidade de São Paulo Instituto de Medicina Tropical de São Paulo, São Paulo, SP, 05403-000, Brazil.
José Pinhata OtochLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil.
Ana Flávia Marçal PessoaLaboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 01246903, Brazil. anabiorq@usp.br.

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 404096/2020-4Coordenação de Aperfeiçoamento de Pessoal de Nível Superior 88887.703169/2022-00Efeom Nutrition S.A. 01/04-21Fundação de Amparo à Pesquisa do Estado de São Paulo 18/14389-0
6 · The paper itself

Abstract

Nutraceutical interventions supporting microbiota and eliciting clinical improvements in metabolic diseases have grown significantly. Chronic stress, gut dysbiosis, and metainflammation have emerged as key factors intertwined with sleep disorders, consequently exacerbating the decline in quality of life. This study aimed to assess the effects of two nutraceutical formulations containing prebiotics (fructooligosaccharides (FOS), galactooligosaccharides (GOS), yeast β-glucans), minerals (Mg, Se, Zn), and the herbal medicine Silybum marianum L. Gaertn., Asteraceae (Milk thistle or Silymarin). These formulations, namely NSupple (without silymarin) and NSupple_Silybum (with silymarin) were tested over 180 days in overweight/obese volunteers from Brazil's southeastern region. We accessed fecal gut microbiota by partial 16S rRNA sequences; cytokines expression by CBA; anthropometrics, quality of life and sleep, as well as metabolic and hormonal parameters, at baseline (T0) and 180 days (T180) post-supplementation. Results demonstrated gut microbiota reshaping at phyla, genera, and species level post-supplementation. The Bacteroidetes phylum, Bacteroides, and Prevotella genera were positively modulated especially in the NSupple_Silybum group. Gut microbiota modulation was associated with improved sleep patterns, quality-of-life perception, cytokines expression, and anthropometric parameters post-supplementation. Our findings suggest that the nutraceutical blends positively enhance cardiometabolic and inflammatory markers. Particularly, NSupple_Silybum modulated microbiota composition, underscoring its potential significance in ameliorating metabolic dysregulation. Clinical trial registry number: NCT04810572. 23/03/2021.

Indexed as

CytokinesDietary SupplementsGastrointestinal MicrobiomeQuality of LifeAdultBrazilDouble-Blind MethodFecesFemaleHumansMaleMiddle AgedMineralsObesityOligosaccharidesPrebioticsCytokinesMineralsOligosaccharidesPrebioticsSilymarin

Identifiers

PMID38750102
PMCPMC11096337

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.