Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota (PREMIUM) in individuals with excessive body weight: a study protocol for a randomised controlled trial Article Swipe
Júlia Montenegro
,
Camila L. P. Oliveira
,
Anissa M. Armet
,
Aloys Berg
,
Arya M. Sharma
,
Laurie Mereu
,
Cristiane Cominetti
,
Sunita Ghosh
,
Caroline Richard
,
Nguyen K. Nguyen
,
Patrice D. Cani
,
Jens Walter
,
Carla M. Prado
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2022-070027
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2022-070027
Introduction Excess body weight is associated with a state of low-grade chronic inflammation and alterations of the gut microbiome. Powdered meal replacements (PMR) have been shown to be an effective strategy for weight management; however, their effect on inflammation and the gut microbiome remains unclear. The aim of this 12-week randomised control clinical trial is to investigate the effects of PMR consumption, here given as a soy-yoghurt-honey formula, on inflammation, gut microbiome and overall metabolism in individuals with excessive body weight. Methods and analysis Healthy adults with excess body weight (n=88) are being recruited and randomly assigned to one of the following groups: (1) Control group (CON): maintaining usual diet for 12 weeks, or (2) PMR group: replacing morning and afternoon snacks daily with a PMR for 12 weeks. Participants are asked to maintain body weight throughout the study and fill out a journal with information about PMR consumption, body weight, food intake, appetite sensations and medications. Three study visits are required: baseline, week 6 and week 12. Outcome measures include systemic inflammatory biomarkers, gut microbiome composition, metabolic blood markers, host energy metabolism, body composition, appetite sensations and host gene expression profile. Ethics and dissemination This research protocol was approved by the University of Alberta Ethics Board (Pro00070712) and adheres to the Canadian Tri-Council Policy statement on the use of human participants in research. Procedures and potential risks are fully discussed with participants. Study findings will be disseminated in peer-reviewed journals, conference presentations and social media. Trial registration number NCT03235804 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2022-070027
- https://bmjopen.bmj.com/content/bmjopen/13/9/e070027.full.pdf
- OA Status
- gold
- Cited By
- 2
- References
- 40
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4386742984
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4386742984Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2022-070027Digital Object Identifier
- Title
-
Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota (PREMIUM) in individuals with excessive body weight: a study protocol for a randomised controlled trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-09-01Full publication date if available
- Authors
-
Júlia Montenegro, Camila L. P. Oliveira, Anissa M. Armet, Aloys Berg, Arya M. Sharma, Laurie Mereu, Cristiane Cominetti, Sunita Ghosh, Caroline Richard, Nguyen K. Nguyen, Patrice D. Cani, Jens Walter, Carla M. PradoList of authors in order
- Landing page
-
https://doi.org/10.1136/bmjopen-2022-070027Publisher landing page
- PDF URL
-
https://bmjopen.bmj.com/content/bmjopen/13/9/e070027.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://bmjopen.bmj.com/content/bmjopen/13/9/e070027.full.pdfDirect OA link when available
- Concepts
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Medicine, Appetite, Microbiome, Weight management, Gut flora, Weight loss, Randomized controlled trial, Systemic inflammation, Meal, Clinical trial, Physiology, Internal medicine, Obesity, Inflammation, Immunology, Bioinformatics, BiologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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2Total citation count in OpenAlex
- Citations by year (recent)
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2025: 2Per-year citation counts (last 5 years)
- References (count)
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40Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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