Mariana Pasqua1, Alessandro Gallo2
1 Editorial Project Manager, Springer Healthcare Italia e Biologa Nutrizionista
2Direttore Generale, Springer Healthcare Italia
Randomised controlled trials (RCTs) are the gold standard for evaluating the effectiveness of health interventions. Since the 1990s, methodological research has highlighted how inadequate trial conduct or reporting is associated with biases, which reduce the credibility and validity of scientific research.
To remedy the lack of adequate reporting, the CONSORT (Consolidated Standards of Reporting Trials) statement was developed in 1996, which represents, in the version updated to 2010, a valid aid for the drafting of RCT reports, favouring completeness, clarity and transparency of reporting (1).
Over the years, extensions to the CONSORT statement have followed for the drafting of specific guidelines for the area of intervention. In 2018, the CONSORT-Nut was registered, i.e., the extension of the CONSORT for randomised controlled trials in the field of nutrition.
In fact, transparency and management of conflicts of interest for RCTs is not limited to the pharmaceutical sector, but also includes the food industry, in particular with reference to the design and reporting of the results of clinical trials in the nutritional field. In particular, in the 1960s, the influence of the sugar industry led to research that downplayed the link between sugar and heart disease.
In 2016, an article published in JAMA (2), revealed that the sugar industry had in fact paid researchers to shift the responsibility for heart disease from sugar to fat. This misleading information has been used to inform nutrition research and guidelines for several decades, with long-lasting and adverse effects on public health.
The lifestyle we lead affects the diseases to which we are predisposed, primary prevention health interventions in the fields of lifestyle and nutrition should guarantee us, in the near future, to manage the risks related to the use or exposure of certain factors that could favour the onset of chronic pathologies such as cardiovascular disease, diabetes or tumours.
Nutritional interventions require careful consideration during study design and execution and careful communication of research questions, just consider that substituting one food for another would imply the substitution of many nutrients (3).
In the science of human nutrition, non-randomised observational studies prevail, in a ratio of 7.3:1 compared to randomised controlled trials. Well, it would be desirable for RCT studies to increase instead, as everyday questions about modest differences in dietary intake require random allocation of exposure to obtain reliable answers (4).
Despite all the studies conducted so far in nutrition, there is still no professional consensus on the definition of a “healthy diet” and dietary guidelines are always at the centre of fierce debates, not to mention that every single nutrient is often associated with opposite results in peer studies. The science of nutrition has become populated with controversial findings, and confirmatory cognitive biases only fuel this confusion (4).
Having a registered protocol and a predefined statistical analysis plan will help make the results more easily interpretable and reliable, but nutrition-related trials are not subject to regulatory oversight, which probably explains the lack of essential details in the papers (3).
The ambitious research program of STAR-NUT (Securing Transparency and Reproducibility in studies of Nutritional Interventions) was born to consolidate reporting standards for randomised controlled trials and systematic reviews of nutritional interventions.
In January 2023, the work of systematic reviews and mapping the existing literature for the development of the CONSORT-Nut was completed.
- Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT Statement 2010: line guida aggiornate per il reporting di trial randomizzati a gruppi paralleli. Evidence 2012;4(7): e1000024.
- Kearns CE, Schmidt LA, Glantz SA. Sugar Industry and Coronary Heart Disease Research: A Historical Analysis of Internal Industry Documents. JAMA Intern Med. 2016 Nov 1;176(11):1680-1685. 1;176(11):1729.
- Silva FM, Adegboye ARA, Curioni C, et al. Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations. BMJ Open 2022;12:
- Trepanowski JF, Ioannidis JPA. Perspective: limiting dependence on nonrandomized studies and improving randomized trials in human nutrition research: why and how. Adv Nutr 2018;9:367–77.