SynthesisEuropean journal of nutrition2022
Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials.
Synthesis in European journal of nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 45 papers, 4 of them syntheses that pooled 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.
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.
Who cites it
45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Efficacy and Safety of Probiotics, Prebiotics and Synbiotics for the Treatment of Functional Constipation in Children: Systematic Review and Network Meta-analysis.Probiotics and antimicrobial proteins · 2026Pooled it
- Stabilized adaptive states in microbiome-human integrated physiology: reframing health and chronic disease as symbiotic biological states.Frontiers in medicine · 2026Pooled it
- Effect of host and gut microbiota-altering interventions on sarcopenia or its defining parameters: a systematic review and meta-analysis of nutrition-based intervention studies.Aging clinical and experimental research · 2025Pooled it
- Pooled it
- Randomized Placebo-Controlled Trial of Psyllium Fiber in Functional Abdominal Pain Disorders in Children.Digestive diseases and sciences · 2026Trial
- Trial
- Body mass index, prebiotic supplementation during pregnancy and gestational diabetes mellitus risk: an effect modification analysis from a randomised controlled trial.Nutrition journal · 2026Trial
- Resistant dextrin promotes beneficial fecal bacteria in high and low fiber diet populations: a randomized, double-blinded, controlled pilot study.Frontiers in nutrition · 2026Trial
- Effect of AG1Frontiers in nutrition · 2026Trial
- Gut microbial community and host intestinal gene expression with combined fish oil and soluble corn fiber compared with corn oil and maltodextrin: A randomized crossover trial in healthy older individuals.The American journal of clinical nutrition · 2025Trial
- The evidence from in vitro primary fibroblasts and a randomized, double-blind, placebo-controlled clinical trial of tuna collagen peptides intake on skin health.Journal of cosmetic dermatology · 2024Trial
- The effects of AG1® supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial.Journal of the International Society of Sports Nutrition · 2024Trial
- The effects of 3-month supplementation with synbiotic on patient-reported outcomes, exercise tolerance, and brain and muscle metabolism in adult patients with post-COVID-19 chronic fatigue syndrome (STOP-FATIGUE): a randomized Placebo-controlled clinical trial.European journal of nutrition · 2024Trial
- Trial
- Trial
- Nutraceutical blends predict enhanced health via microbiota reshaping improving cytokines and life quality: a Brazilian double-blind randomized trial.Scientific reports · 2024Trial
- Trial
- Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial.Pediatric research · 2023Trial
- Improvement of Bladder Dysfunction byPharmaceuticals (Basel, Switzerland) · 2026Article
- Probiotic supplementation for anxiety symptoms in people with Parkinson's disease: a randomized, double-blind, placebo-controlled trial.NPJ Parkinson's disease · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
purposeMaltodextrin (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.
methodsWe 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.
resultsOf 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.
conclusionOrally-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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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.