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European Journal of Nutrition

Erschienen in:

01.03.2022 | Review

Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials

verfasst von: Rawan Almutairi, Abigail Raffner Basson, Pamela Wearsh, Fabio Cominelli, Alexander Rodriguez-Palacios

Erschienen in: European Journal of Nutrition | Ausgabe 6/2022

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Abstract

Purpose

Maltodextrin (MDX) is a polysaccharide food additive commonly used as oral placebo/control to investigate treatments/interventions in humans. The aims of this study were to appraise the MDX effects on human physiology/gut microbiota, and to assess the validity of MDX as a placebo-control.

Methods

We performed a systematic review of randomized-placebo-controlled clinical trials (RCTs) where MDX was used as an orally consumed placebo. Data were extracted from study results where effects (physiological/microbial) were attributed (or not) to MDX, and from study participant outcomes data, before-and-after MDX consumption, for post-publication ‘re-analysis’ using paired-data statistics.

Results

Of two hundred-sixteen studies on ‘MDX/microbiome’, seventy RCTs (n = 70) were selected for analysis. Supporting concerns regarding the validity of MDX as a placebo, the majority of RCTs (60%, CI 95% = 0.48–0.76; n = 42/70; Fisher-exact p = 0.001, expected < 5/70) reported MDX-induced physiological (38.1%, n = 16/42; p = 0.005), microbial metabolite (19%, n = 8/42; p = 0.013), or microbiome (50%, n = 21/42; p = 0.0001) effects. MDX-induced alterations on gut microbiome included changes in the Firmicutes and/or Bacteroidetes phyla, and Lactobacillus and/or Bifidobacterium species. Effects on various immunological, inflammatory markers, and gut function/permeability were also documented in 25.6% of the studies (n = 10/42). Notably, there was considerable variability in the direction of effects (decrease/increase), MDX dose, form (powder/pill), duration, and disease/populations studied. Overall, only 20% (n = 14/70; p = 0.026) of studies cross-referenced MDX as a justifiable/innocuous placebo, while 2.9% of studies (n = 2/70) acknowledged their data the opposite.

Conclusion

Orally-consumed MDX often (63.9% of RCTs) induces effects on human physiology/gut microbiota. Such effects question the validity of MDX as a placebo-control in human clinical trials.

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Titel: Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials
verfasst von: Rawan Almutairi
Abigail Raffner Basson
Pamela Wearsh
Fabio Cominelli
Alexander Rodriguez-Palacios
Publikationsdatum: 01.03.2022
Verlag: Springer Berlin Heidelberg
Erschienen in: European Journal of Nutrition / Ausgabe 6/2022
Print ISSN: 1436-6207
Elektronische ISSN: 1436-6215
DOI: https://doi.org/10.1007/s00394-022-02802-5

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Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials

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