Trial reportEuropean journal of clinical nutrition2026
Trimethylamine N-oxide (TMAO) as a prognostic marker among patients at nutritional risk. A secondary analysis of the randomized clinical trial EFFORT.
Trial report in European journal of clinical nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02517476 (Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial), which is not on this map. Not yet cited in PubMed.
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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.
Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial: The EFFORT Trial
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Authors and funding
8 authors.
Funding
Abstract
backgroundTrimethylamine N-oxide (TMAO), a metabolite produced by the gut microbiota, is highly influenced by dietary factors and is linked to negative health outcomes including all-cause mortality and cardiovascular events. We evaluated the prognostic value of TMAO among hospitalized patients at nutritional risk participating in the Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) regarding clinical outcomes and response to nutritional support. CLINICAL
trial registrationclinicaltrials.gov as NCT02517476 (registered 7 August 2015)
methodsThis secondary analysis is based on the randomized-controlled EFFORT trial, which compared individualized nutritional therapy with usual care in medical inpatients at nutritional risk. We studied the association of admission TMAO concentrations with all-cause mortality after 180 days (primary endpoint) and major adverse cardiovascular events (MACE) using quartile-based regression analysis.
resultsAmong 218 patients with available TMAO measurements, those in higher quartiles showed an increased all-cause mortality compared to the lowest quartile after 180 days (adjusted HR 1.92 95% CI 1.03-3.56, p = 0.04) and 5 years (adjusted HR 2.01 95% CI 1.23-3.31, p = 0.006). A similar trend was observed for MACE. We found no significant associations between dietary factors or nutritional history and admission TMAO levels, nor was TMAO predictive regarding the response to nutritional therapy.
conclusionThe risk of mortality over six months nearly doubled in patients at risk of malnutrition with elevated baseline TMAO levels. Additional research is needed to determine if dietary interventions can successfully modulate TMAO levels and, in turn, improve clinical outcomes.
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