Evidence map›Paper›PMID 35837981›Full record

Trial reportDiabetes, obesity & metabolism2022

TOTUM-63, a plant-based polyphenol-rich extract, improves glycaemic control in subjects with prediabetes or early stage newly-diagnosed type 2 diabetes in a randomized, double-blind, placebo-controlled trial.

Pascal Sirvent, Vivien Chavanelle, Yolanda F Otero, Maxime Bargetto, Florian Le Joubioux, Nathalie Boisseau, Thierry Maugard, Murielle Cazaubiel, Bruno Pereira, Bruno Guigas and 4 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 16% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. 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

14 authors at 5 institutions in 4 countries.

Pascal SirventValbiotis R&D Center, Valbiotis, Perigny, France.
Vivien ChavanelleValbiotis R&D Center, Valbiotis, Perigny, France.
Yolanda F OteroValbiotis R&D Center, Valbiotis, Perigny, France.
Maxime BargettoValbiotis R&D Center, Valbiotis, Perigny, France.
Florian Le JoubiouxValbiotis R&D Center, Valbiotis, Perigny, France.
Nathalie BoisseauLaboratoire AME2P, Université Clermont Auvergne, Clermont-Ferrand, France.
Thierry MaugardEquipe BCBS (Biotechnologies et Chimie des Bioressources pour la Santé), La Rochelle Université, UMR CNRS 7266 LIENSs, La Rochelle, France.
Murielle CazaubielValbiotis R&D Center, Valbiotis, Perigny, France.
Bruno PereiraCHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation, Clermont-Ferrand, France.
Bruno GuigasDepartment of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-8856-5799
Samy HadjadjDépartement d'Endocrinologie, Diabétologie et Nutrition, l'Institut du Thorax, INSERM, CNRS, UNIV Nantes, CHU Nantes, Nantes, France.ORCID 0000-0001-7110-6994
Sebastien L PeltierValbiotis R&D Center, Valbiotis, Perigny, France.
André MaretteQuebec Heart and Lung Institute, Department of Medicine, Faculty of Medicine, Laval University, Quebec, Canada.
Jean-Marie BardLaboratoire de Biochimie Générale et Appliquée, UFR de Pharmacie, ISOMer-UE 2160, IUML-Institut Universitaire Mer et Littoral-FR3473 CNRS, Université de Nantes, Nantes, France.ORCID 0000-0002-9123-8123
Centre National de la Recherche Scientifique · FRInstitut Génétique, Reproduction et Développement · FRLeiden University Medical Center · NLMontreal Heart Institute · CAUniversité Clermont Auvergne · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe plant-based polyphenol-rich extract TOTUM-63 improves glucose homeostasis in various preclinical models of obesity and type 2 diabetes (T2D). A pilot exploratory study showed that TOTUM-63 has good safety and tolerability profiles, and beneficial effects on postprandial glucose control in healthy individuals with overweight. The aim of this study was to assess the effects of TOTUM-63 on glycaemic control in individuals with prediabetes or early stage newly-diagnosed T2D (which does not require pharmacological treatment). MATERIALS AND

methodsThis study was a multicentre, randomized, double-blind, placebo-controlled trial. Individuals with prediabetes or early stage newly-diagnosed T2D and with overweight/abdominal obesity received TOTUM-63 (5 g/day) or placebo for 6 months. The primary outcome was the change in fasting blood glucose.

resultsFifty-one participants (age: 57.1 ± 10 years; body mass index: 31.3 ± 5.7 kg.m

conclusionsTOTUM-63 lowered fasting blood glucose in participants with impaired fasting glycaemia and glucose intolerance. Moreover, TOTUM-63 showed a good safety and tolerability profile and improved several metabolic syndrome features. Therefore, TOTUM-63 is a promising candidate for T2D prevention.

Indexed as

Diabetes Mellitus, Type 2Prediabetic StateAgedBlood GlucoseDouble-Blind MethodFemaleGlycemic ControlHumansMaleMiddle AgedObesityOverweightPlant ExtractsPolyphenolsBlood GlucosePlant ExtractsPolyphenolsbotanical extractdiabeticglycaemiametabolic syndromeprediabeticTOTUM-63weight management

Identifiers

PMID35837981
PMCPMC9796323
OpenAlexW4285589669

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.