Evidence map›Paper›PMID 26988693›Full record

Trial reportEuropean journal of nutrition2017

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

Somayyeh Firouzi, Hazreen Abdul Majid, Amin Ismail, Nor Azmi Kamaruddin, Mohd-Yusof Barakatun-Nisak

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

Trial report in European journal of nutrition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06959043 (Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes), which is not on this map. Cited by 90 papers, 31 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 31 pooled it
7.7field-weighted citation impact, top 2% 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.

NCT06959043 narecruitingnot on this mapstarted 2022, after this paper: background citation

Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise

TypeinterventionalSponsorMaria Elizabeth Rossi da SilvaRan2022 to 2026Enrolled60ConditionsType 2 Diabetes Mellitus (T2DM), Insulin Resistance, Inflamation, Gut MicrobiomesArmsProbiotic Supplementation, Placebo Administration
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 31 syntheses or guidelines pooled it, 216 citations in OpenAlex.

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30 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 3 institutions in 1 country.

Somayyeh FirouziDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia.
Hazreen Abdul MajidDepartment of Social and Preventive Medicine, Faculty of Medicine, Centre for Population Health, University of Malaya, Kuala Lumpur, Malaysia.
Amin IsmailDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia.
Nor Azmi KamaruddinDepartment of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Mohd-Yusof Barakatun-NisakDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia. bnisak@upm.edu.my.
Universiti Putra Malaysia · MYNational University of Malaysia · MYUniversity of Malaya · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimEvidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes.

designA randomized, double-blind, parallel-group, controlled clinical trial.

settingDiabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.

participantsA total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. OUTCOMES: Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. STATISTICAL ANALYSIS: Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.

resultsWith respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract.

conclusionProbiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

Indexed as

AdultAgedBifidobacteriumBlood GlucoseC-Reactive ProteinDiabetes Mellitus, Type 2DietDietary CarbohydratesDietary FatsDietary ProteinsDouble-Blind MethodExerciseFemaleGastrointestinal MicrobiomeGlycated HemoglobinHumansBlood GlucoseC-Reactive ProteinDietary CarbohydratesDietary FatsDietary ProteinsGlycated HemoglobinInsulinBlood pressureGlycated hemoglobinGlycemic controlHigh-sensitivity C-reactive proteinHomeostasis model assessment-estimated insulin resistanceLipid profileProbioticsType 2 diabetes mellitus

Identifiers

PMID26988693
OpenAlexW2301014044

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.