Evidence map›Paper›PMID 32417946›Full record

Trial reportEuropean journal of nutrition2021

Impact of a short-term synbiotic supplementation on metabolic syndrome and systemic inflammation in elderly patients: a randomized placebo-controlled clinical trial.

Arrigo F G Cicero, Federica Fogacci, Marilisa Bove, Marina Giovannini, Claudio Borghi

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06158152 (A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Systemic Effect on Immunoinflammatory and Metabolic Status of an Oral Supplementation With AM3 in Patients With Metabolic Syndrome.), which is not on this map. Cited by 67 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 8 pooled it
5.9field-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.

NCT06158152 narecruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Systemic Effect on Immunoinflammatory and Metabolic Status of an Oral Supplementation With AM3 in Patients With Metabolic Syndrome.

TypeinterventionalSponsorIndustrial Farmacéutica Cantabria, S.A.Ran2024 to 2026Enrolled48ConditionsMetabolic SyndromeArmsAM3 + Probiotic, Placebo, AM3
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 8 syntheses or guidelines pooled it, 127 citations in OpenAlex.

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  6. Probiotics for the treatment of depression and its comorbidities: A systemic review.Frontiers in cellular and infection microbiology · 2023
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  13. Noninvasive instrumental evaluation of coenzyme QBioFactors (Oxford, England) · 2022
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7 more citing papers are in PubMed but not listed here.

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

5 authors at 1 institution in 1 country.

Arrigo F G CiceroDepartment of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy. arrigo.cicero@unibo.it.ORCID http://orcid.org/0000-0002-4367-3884
Federica FogacciDepartment of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
Marilisa BoveDepartment of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
Marina GiovanniniDepartment of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
Claudio BorghiDepartment of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
University of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe connection between gut microbiota imbalance, inflammation and its role in the pathogenesis of metabolic syndrome (MetS) clustering factors has been increasingly recognized. However, data on the efficacy of probiotics supplementation on MetS components are few and almost lacking in the elderly. To address this issue, we conducted a randomized, double-blind, placebo-controlled, parallel-group, clinical study on a large sample of MetS elderly patients.

methodsAfter 14 days of diet and physical activity standardization, 60 elderly patients were randomized to treatment with a synbiotic formula of Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066 and Lactobacillus reuteri PBS072 with active prebiotics or placebo. Patients were evaluated anamnestically and by the execution of a physical examination and laboratory and haemodynamic analyses at the baseline and after 60 days of treatment. At enrollment and at the end of the trial, all enrolled patients complete the EuroQol-5 Dimension (EQ-5D) questionnaire.

resultsThrough the 2-month period of treatment, patients who received active treatment experienced a statistically significant improvement in waist circumference and in fasting plasma insulin, total cholesterol, high-density lipoprotein cholesterol, non-HDL-C, triglycerides (TG), low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and tumor necrosis factor alpha serum levels, compared both to the baseline and the control group. Visceral adiposity index improvement in the synbiotic treatment group was significantly greater than in placebo group. Compared to baseline, treatment with synbiotics also significantly reduced mean arterial pressure and fasting plasma glucose. All treatment groups demonstrated a significant decrease in TG. TG reduction in the synbiotic group was significantly greater than in the control group. The EQ-5D VAS questionnaire significantly improved only in probiotics-treated subjects.

conclusionTreatment with a synbiotic formula of L. plantarum PBS067, L. acidophilus PBS066 and L. reuteri PBS072 with active prebiotics decreased MetS syndrome prevalence, several cardiovascular risk factors and markers of insulin resistance in elderly patients.

Indexed as

Gastrointestinal MicrobiomeMetabolic SyndromeProbioticsSynbioticsAgedDouble-Blind MethodHumansInflammationElderlyInflammationMetabolic syndromeProbiotics

Identifiers

PMID32417946
OpenAlexW3024345160

What OpenQuestion 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 OpenQuestion graph.