Evidence map›Paper›PMID 32642971›Full record

Trial reportEuropean journal of nutrition2021

Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes.

Raylene A Reimer, Sean Wharton, Tim J Green, Priya Manjoo, Hena R Ramay, Michael R Lyon, Roland J Gahler, Simon Wood

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 NCT01644201 (A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a Highly Viscous Non-starch Polysaccharide), which is not on this map. Cited by 14 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 7 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01644201 phase3terminatednot on this map

A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a Highly Viscous Non-starch Polysaccharide (PolyGlycopleX® - PGX®), on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics Enrolled in a Medically Supervised Weight Management Program.

TypeinterventionalSponsorInovoBiologic Inc.Ran2012 to 2016Enrolled100ConditionsType II Diabetes Mellitus, ObesityArmsPolyGlycopleX® - PGX®, Rice Flour (placebo)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 7 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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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

8 authors at 4 institutions in 2 countries.

Raylene A ReimerFaculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada. reimer@ucalgary.ca.ORCID http://orcid.org/0000-0001-5088-7947
Sean WhartonThe Wharton Medical Clinic and Weight Management Centre, Hamilton, ON, Canada.
Tim J GreenHealthy Mothers, Babies, and Children, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
Priya ManjooDepartment of Medicine, Vancouver Island Health Authority, University of Victoria, University of British Columbia, Victoria, Canada.
Hena R RamayInternational Microbiome Centre, University of Calgary, Calgary, AB, Canada.
Michael R LyonObesity Medicine and Diabetes Institute, Coquitlam, BC, Canada.
Roland J GahlerFactors Group of Nutritional Products Inc. R & D, Burnaby, BC, Canada.
Simon WoodInovoBiologic Inc., Calgary, AB, Canada.
University of British Columbia · CAUniversity of Calgary · CAIsland Health · CASouth Australian Health and Medical Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSoluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX

methodsIn a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15-20 g/day) or isocaloric placebo (rice flour, 6.4-8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota.

resultsCompared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia.

conclusionAdding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D. CLINICAL TRIAL: This trial was registered at ClinicalTrials.gov as NCT01644201.

Indexed as

Diabetes Mellitus, Type 2Weight Reduction ProgramsAdultBlood GlucoseDietary FiberDouble-Blind MethodGlycemic ControlHumansObesityBlood GlucoseDietary FiberDietary fibreGlycemic controlGut microbiotaHyperlipidemiaPolyGlycopleX®

Identifiers

PMID32642971
OpenAlexW3041783878

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.