Effect of nutritionally modified infant formula on academic performance: linkage of seven dormant randomised controlled trials to national education data

Verfürden, Maximiliane L; Gilbert, Ruth; Lucas, Alan; Jerrim, John; Fewtrell, Mary

doi:10.1136/bmj-2021-065805

Cited by 14 publications

(6 citation statements)

References 38 publications

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“…This causal link is reported despite recent evidence failing to substantiate the association. 29 30 Other common claims, such as for prebiotics, probiotics, and synbiotics and for strengthening and supporting a healthy immune system also do not have strong substantiation in the scientific literature. 31 It is worth noting that claims were frequently made in the absence of a link to a specific ingredient.…”

Section: Discussionmentioning

confidence: 99%

Health and nutrition claims for infant formula: international cross sectional survey

Cheung

Petrou

Helfer

et al. 2023

BMJ

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ObjectivesTo review available health and nutrition claims for infant formula products in multiple countries and to evaluate the validity of the evidence used for substantiation of claims.DesignInternational cross sectional survey.SettingPublic facing and healthcare professional facing company owned or company managed formula industry websites providing information about products marketed for healthy infants delivered at full term in 15 countries: Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020-22.Main outcome measuresNumber and type of claims made for each product and ingredient. References cited were reviewed and risk of bias was assessed for registered clinical trials using the Cochrane risk of bias tool, and for systematic reviews using the Risk Of Bias in Systematic reviews tool.Results757 infant formula products were identified, each with a median of two claims (range from 1 (Australia) to 4 (US)), and 31 types of claims across all products. Of 608 products with ≥1 claims, the most common claim types were “helps/supports development of brain and/or eyes and/or nervous system” (323 (53%) products, 13 ingredients), “strengthens/supports a healthy immune system” (239 (39%) products, 12 ingredients), and “helps/supports growth and development” (224 (37%) products, 20 ingredients). 41 groups of ingredients were associated with ≥1claims, but many claims were made without reference to a specific ingredient (307 (50%) products). The most common groups of ingredients cited in claims were long chain polyunsaturated fatty acids (278 (46%) products, 9 different claims); prebiotics, probiotics, or synbiotics (225 (37%) products, 19 claims); and hydrolysed protein (120 (20%) products, 9 claims). 161/608 (26%) products with ≥1 claims provided a scientific reference to support the claim—266 unique references were cited for 24 different claim types for 161 products. The reference types most frequently cited were clinical trials (50%, 134/266) and reviews (20%, 52/266). 28% (38/134) of referenced clinical trials were registered, 14% (19/134) prospectively. 58 claims referred to 32 registered clinical trials, of which 51 claims (27 trials) related to a randomised comparison. 46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias.ConclusionsMost infant formula products had at least one health and nutrition claim. Multiple ingredients were claimed to achieve similar health or nutrition effects, multiple claims were made for the same ingredient type, most products did not provide scientific references to support claims, and referenced claims were not supported by robust clinical trial evidence.

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Section: Discussionmentioning

confidence: 99%

Health and nutrition claims for infant formula: international cross sectional survey

Cheung

Petrou

Helfer

et al. 2023

BMJ

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“…There are also a number of interventions and outcomes with no single phenotype which could be instrumented with GWAS variants, making MR approaches difficult, although sometimes possible with innovative MR approaches. 160 This is especially true of lifestyle interventions—such as different forms of psychological therapy, complex diet regimens 161 and fasting. Absent or limited heritability of a number of interventions and conditions, such as rehabilitation and traumatic injury makes MR approaches inaccessible.…”

Section: Discussionmentioning

confidence: 99%

Systematic comparison of Mendelian randomisation studies and randomised controlled trials using electronic databases

Sobczyk,

Zheng,

Davey Smith

et al. 2023

BMJ Open

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ObjectiveTo scope the potential for (semi)-automated triangulation of Mendelian randomisation (MR) and randomised controlled trials (RCTs) evidence since the two methods have distinct assumptions that make comparisons between their results invaluable.MethodsWe mined ClinicalTrials.Gov, PubMed and EpigraphDB databases and carried out a series of 26 manual literature comparisons among 54 MR and 77 RCT publications.ResultsWe found that only 13% of completed RCTs identified in ClinicalTrials.Gov submitted their results to the database. Similarly low coverage was revealed for Semantic Medline (SemMedDB) semantic triples derived from MR and RCT publications –36% and 12%, respectively. Among intervention types that can be mimicked by MR, only trials of pharmaceutical interventions could be automatically matched to MR results due to insufficient annotation with Medical Subject Headings ontology. A manual survey of the literature highlighted the potential for triangulation across a number of exposure/outcome pairs if these challenges can be addressed.ConclusionsWe conclude that careful triangulation of MR with RCT evidence should involve consideration of similarity of phenotypes across study designs, intervention intensity and duration, study population demography and health status, comparator group, intervention goal and quality of evidence.

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“…There are also a number of interventions and outcomes with no single phenotype which could be instrumented with GWAS variants, making MR approaches difficult, although sometimes possible with innovative MR approaches 153 . This is especially true of lifestyle interventions – such as different forms of psychological therapy, complex diet regimens 154 and fasting. Absent or limited heritability of a number of interventions and conditions, such as rehabilitation and traumatic injury makes MR approaches inaccessible.…”

Section: Discussionmentioning

confidence: 99%

Systematic comparison of Mendelian randomization studies and randomized controlled trials using electronic databases

Sobczyk

Smith

Gaunt

2022

Preprint

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Mendelian Randomization (MR) uses genetic instrumental variables to make causal inferences. Whilst sometimes referred to as "nature's randomized trial", it has distinct assumptions that make comparisons between the results of MR studies with those of actual randomized controlled trials (RCTs) invaluable. To scope the potential for (semi-)-automated triangulation of MR and RCT evidence, we mined ClinicalTrials.Gov, PubMed and EpigraphDB databases and carried out a series of 26 manual literature comparisons among 54 MR and 77 RCT publications. We found that only 11% of completed RCTs identified in ClinicalTrials.Gov submitted their results to the database. Similarly low coverage was revealed for Semantic Medline (SemMedDB) semantic triples derived from MR and RCT publications - 25% and 12%, respectively. Among intervention types that can be mimicked by MR, only trials of pharmaceutical interventions could be automatically matched to MR results due to insufficient annotation with MeSH ontology. A manual survey of the literature highlighted the potential for triangulation across a number of exposure/outcome pairs if these challenges can be addressed. We conclude that careful triangulation of MR with RCT evidence should involve consideration of similarity of phenotypes across study designs, intervention intensity and duration, study population demography and health status, comparator group, intervention goal and quality of evidence.

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Effect of nutritionally modified infant formula on academic performance: linkage of seven dormant randomised controlled trials to national education data

Cited by 14 publications

References 38 publications

Health and nutrition claims for infant formula: international cross sectional survey

Health and nutrition claims for infant formula: international cross sectional survey

Systematic comparison of Mendelian randomisation studies and randomised controlled trials using electronic databases

Systematic comparison of Mendelian randomization studies and randomized controlled trials using electronic databases

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