The effects of a powdered meal replacement on inflammation, gut microbiota, and metabolism in people with excess body weight: A randomized controlled trial

dc.contributor.authorMontenegro, Julia
dc.contributor.authorOliveira, Camila L.P.
dc.contributor.authorNguyen, Nguyen Khoi
dc.contributor.authorArmet, Anissa M.
dc.contributor.authorBerg, Aloys
dc.contributor.authorSharma, Arya M.
dc.contributor.authorMereu, Laurie
dc.contributor.authorCominetti, Cristiane
dc.contributor.authorGhosh, Sunita
dc.contributor.authorCani, Patrice D.
dc.contributor.authorRichard, Caroline
dc.contributor.authorWalter, Jens
dc.contributor.authorPrado, Carla M.
dc.contributor.funderAlmased Wellness-GmbH
dc.contributor.funderCanadian Foundation for Innovation, 34115
dc.contributor.funderCanada Research Chairs
dc.contributor.funderCampus Alberta Innovation Program
dc.contributor.funderMitacs Accelerate International
dc.contributor.funderFonds De La Recherche Scientifique - FNRS, FNRS, T.0032.25
dc.contributor.funderFonds De La Recherche Scientifique - FNRS, FNRS, J.0027.22
dc.contributor.funderWalloon excellence in life sciences and biotechnology, WELBIO-CR-2022A-02P
dc.contributor.funderAlberta Diabetes Institute
dc.contributor.funderFresenius Kabi
dc.contributor.funderAbbott Nutrition
dc.contributor.funderAMRA Medical Inc.
dc.contributor.funderAlmased Wellness GmbH
dc.contributor.funderAbbVie
dc.contributor.funderAmgen Incorporated
dc.contributor.funderAstraZeneca
dc.contributor.funderCurrax
dc.contributor.funderEli Lilly
dc.contributor.funderNovo Nordisk
dc.contributor.funderNutricia
dc.contributor.fundera Nestlé Health Science Company
dc.contributor.funderBoehringer Ingelheim GmbH
dc.date.accessioned2026-10-19T16:15:01Z
dc.date.available2026-10-19T16:15:01Z
dc.date.issued2026-06-04
dc.description.abstractBackground: Excess body weight is associated with chronic low-grade inflammation and metabolic abnormalities, such as insulin resistance, and dyslipidemia. Objectives: This study aimed to assess the impact of a soy protein-yogurt-honey powdered meal replacement (PMR) on inflammation, gut microbiota, and metabolism in individuals with excess body weight and in weight-stable conditions. Methods: The Powdered meal REplacement on MetabolIsm and gUt Microbiota (PREMIUM) Study was a 12-week, parallel-arm, randomized controlled trial. Participants (body mass index: 25–37 kg/m2) were randomized into either control (CON; usual diet, n = 34) or PMR (2 daily doses added to usual diet, n = 29) groups, maintaining a stable body weight. Assessments occurred at baseline, week 6, and week 12, and included inflammation markers (primary outcome: IL-6), gut microbiota diversity and composition (secondary outcome), metabolic blood markers (glucose and lipid profile), body composition (via dual-energy X-ray absorptiometry), and dietary intake. Data of completers were analyzed by 2-way repeated measures analysis of variance or generalized estimating equations with Bonferroni-corrected post hoc tests. Between-group differences in changes over time are expressed as mean and 95% confidence intervals. Results: Adherence to PMR was 98% of total doses, which increased protein intake [6.53% (5.04%, 8.02%), P < 0.001] and decreased fat intake [−5.23% (−7.10%, −3.35%), P < 0.001] compared with CON. By design, body weight remained stable. There were no changes in IL-6 [−0.01 (−0.47, 0.45) pg/mL, P = 0.412], with a low statistical power of 13.7%. Minor changes in gut microbiota composition included an increase in relative abundance of Subdoligranulum (0.72 Log2 fold-change, q = 0.002). In exploratory outcomes, PMR increased lean soft tissue [0.57 (0.12, 1.02) kg, P = 0.014] and reduced total cholesterol [−0.33 (−0.58, −0.08) mmol/L, P = 0.01] and low-density lipoprotein cholesterol [−0.28 (−0.46, −0.10) mmol/L, P = 0.003]. Conclusions: In this population, PMR intake did not improve chronic low-grade inflammation and had limited effects on gut microbiota, but was associated with improvements in lean soft tissue and lipid profile that warrant further exploration.This trial was registered at clinicaltrials.gov as NCT03235804 on August 1, 2017.en
dc.description.sponsorshipAlmased Wellness-GmbH
dc.description.sponsorshipCanadian Foundation for Innovation|34115|John R Evans Leaders Fund
dc.description.sponsorshipCanada Research Chair
dc.description.sponsorshipCampus Alberta Innovation Program
dc.description.sponsorshipMitacs Accelerate International
dc.description.sponsorshipFonds de la Recherche Scientifique (FNRS)|T.0032.25
dc.description.sponsorshipFonds de la Recherche Scientifique (FNRS)|J.0027.22
dc.description.sponsorshipWalloon excellence in life sciences and biotechnology|WELBIO-CR-2022A-02P
dc.description.sponsorshipAlberta Diabetes Institute
dc.description.sponsorshipFresenius Kabi
dc.description.sponsorshipAbbott Nutrition
dc.description.sponsorshipAMRA Medical Inc.
dc.description.sponsorshipAmased Wellness-GmbH
dc.description.sponsorshipAbbVie
dc.description.sponsorshipAmgen
dc.description.sponsorshipAstraZeneca
dc.description.sponsorshipCurrax
dc.description.sponsorshipLilly
dc.description.sponsorshipNovo Nordisk
dc.description.sponsorshipNutricia
dc.description.sponsorshipNestle Health Science
dc.description.sponsorshipBoehringer Ingelheim
dc.description.versionPublished Version
dc.format.extent15
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid101595
dc.identifier.authororcidMontenegro, Julia
dc.identifier.authororcidOliveira, Camila L.P.
dc.identifier.authororcidNguyen, Nguyen Khoi
dc.identifier.authororcidArmet, Anissa M.
dc.identifier.authororcidBerg, Aloys
dc.identifier.authororcidSharma, Arya M.
dc.identifier.authororcidMereu, Laurie
dc.identifier.authororcidCominetti, Cristiane
dc.identifier.authororcidGhosh, Sunita
dc.identifier.authororcidCani, Patrice D.
dc.identifier.authororcidRichard, Caroline
dc.identifier.authororcidWalter, Jens§0000-0003-1754-172X
dc.identifier.authororcidPrado, Carla M.
dc.identifier.citationMontenegro, J, Oliveira, C L P, Nguyen, N K, Armet, A M, Berg, A, Sharma, A M, Mereu, L, Cominetti, C, Ghosh, S, Cani, P D, Richard, C, Walter, J & Prado, C M 2026, 'The effects of a powdered meal replacement on inflammation, gut microbiota, and metabolism in people with excess body weight: A randomized controlled trial', Journal of Nutrition, vol. 156, no. 7, 101595, pp. 1-15. https://doi.org/10.1016/j.tjnut.2026.101595
dc.identifier.doi10.1016/j.tjnut.2026.101595
dc.identifier.endpage15
dc.identifier.issn0022-3166
dc.identifier.issued7
dc.identifier.journaltitleJournal of Nutrition
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19463
dc.identifier.volume156
dc.language.isoen
dc.publisherElsevier B.V.
dc.relation.urihttps://www.scopus.com/pages/publications/105040781452
dc.rights© 2026, authors. Published by Elsevier Inc. on behalf of American Society for Nutrition. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/)
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.statusPeer reviewed
dc.subjectBody composition
dc.subjectGut microbiome
dc.subjectInflammation
dc.subjectMeal replacement
dc.subjectObesity
dc.subject[APCMicrobiome]
dc.subject[Microbiology]
dc.titleThe effects of a powdered meal replacement on inflammation, gut microbiota, and metabolism in people with excess body weight: A randomized controlled trialen
dc.typeArticle (peer-reviewed)
Files
Original bundle
Now showing 1 - 2 of 2
Loading...
Thumbnail Image
Name:
1-s2.0-S0022316626002440-main.pdf
Size:
5.09 MB
Format:
Adobe Portable Document Format
Description:
Published Version
Loading...
Thumbnail Image
Name:
1-s2.0-S0022316626002440-mmc1.docx
Size:
892.75 KB
Format:
Microsoft Word XML
Description:
Published Version