Diet and Nutrition - Resources for research in DGBI - Rome Foundation

Publications relating to study design of diet, nutrition and/or DGBI studies

The following publications provide recommendations on best research practice in studies involving diet and/or DGBI.

Nutrients, foods and diets trial design	Reference	Link to journal website
Clinical trial study design for dietary interventions in DGBI	Staudacher HM, Yao CK, Chey WD, Whelan K. Optimal Design of Clinical Trials of Dietary Interventions in Disorders of Gut-Brain Interaction. Am J Gastroenterol. 2022; 117(6): 973-984.	https://journals.lww.com/ajg/fulltext/2022/06000/optimal_design_of_clinical_trials_of_dietary.30.aspx
Considerations for control groups, placebos and blinding in dietary intervention trials	Staudacher HM, Irving PM, Lomer MCE, Whelan K. The challenges of control groups, placebos and blinding in clinical trials of dietary interventions. Proc Nutr Soc. 2017; 76(3): 203-212.	https://www.cambridge.org/core/journals/proceedings-of-the-nutrition-society/article/challenges-of-control-groups-placebos-and-blinding-in-clinical-trials-of-dietary-interventions/CD0D06FBF583C0E1DE908002A4133335
Clinical trial study design for dietary interventions in DGBI	Yao CK, Gibson PR, Shepherd SJ. Design of clinical trials evaluating dietary interventions in patients with functional gastrointestinal disorders. Am J Gastroenterol. 2013; 108(5): 748-58.	https://journals.lww.com/ajg/abstract/2013/05000/design_of_clinical_trials_evaluating_dietary.18.aspx
Study design for feeding trials in nutrition research	Tien DS, Hockey M, So D, Stanford J, Clarke ED, Collins CE, Staudacher HM. Recommendations for Designing, Conducting, and Reporting Feeding Trials in Nutrition Research. Adv Nutr. 2024; 15(10): 100283.	https://www.sciencedirect.com/science/article/pii/S2161831324001170
Recommendations for designing, implementing and reporting control interventions	Hohenschurz-Scmidt et al. Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement. BMJ. 2023; 381: e072108	https://www.bmj.com/content/381/bmj-2022-072108
Study design and reporting for feeding trials measuring the dietary metabolome	1. Ferguson JJA, Clarke ED, Stanford J, et al. Strengthening the reporting of diet item details in feeding studies measuring the dietary metabolome: The DID-METAB core outcome set statement. Eur J Clin Invest. 2025; 55:e70030. 2. Ferguson JJA, Clarke ED, Stanford J, et al, Perspective: Diet Item Details: Reporting Checklist for Feeding Studies Measuring the Dietary Metabolome (DID-METAB Checklist) – Explanation and Elaboration Report on the Development of the Checklist by the DID-METAB Delphi Working Group. Adv Nutr. 2025;16(5) doi.org/10.1016/j.advnut.2025.100420.	1. https://onlinelibrary.wiley.com/doi/10.1111/eci.70030 2. https://www.sciencedirect.com/science/article/pii/S2161831325000560?via%3Dihub
Dietary assessment and analysis methods including specific considerations for population sub groups	Thompson, Frances E., and Amy F. Subar. Dietary assessment methodology. Nutrition in the Prevention and Treatment of Disease (2017): 5-48.	https://epi.grants.cancer.gov/dietary-assessment/Chapter%201_Coulston.pdf
Dietary assessment methods in epidemiologic studies	Shim, Jee-Seon, Kyungwon Oh, and Hyeon Chang Kim. Dietary assessment methods in epidemiologic studies. Epidemiology and health 36 (2014).	https://e-epih.org/journal/view.php?doi=10.4178/epih/e2014009
Methods for assessing and analysing FODMAP intake	Nybacka S, Störsrud S, Liljebo T, Le Nevé B, Törnblom H, Simrén M, & Winkvist A. Within-and between-subject variation in dietary intake of fermentable oligo-, di-, monosaccharides, and polyols among patients with irritable bowel syndrome. Current developments in nutrition, 2019. 3(2), nzy101.	https://www.sciencedirect.com/science/article/pii/S2475299122129896

	Microbiome, probiotic and prebiotic trial design
Study design for microbiome research	Warmbrunn MV, Attaye I, Herrema H, Nieuwdorp M. Protocol Standardization of Microbiome Studies—Daunting but Necessary. Gastroenterology. 2022; 162(7): 1822-1824.	https://www.gastrojournal.org/article/S0016-5085(22)00268-2/fulltext
Study design for microbiome research with dietary interventions	Swann JR, et al. Considerations for the design and conduct of human gut microbiota intervention studies relating to foods. European Journal of Nutrition. 2020; 59:3347–3368.	https://link.springer.com/article/10.1007/s00394-020-02232-1
Study design for prebiotic and probiotic trials in the context of diet and the gut microbiome	Whelan, K., Alexander, M., Gaiani, C. et al. Design and reporting of prebiotic and probiotic clinical trials in the context of diet and the gut microbiome. Nat Microbiol 2024; 9, 2785–2794.	https://www.nature.com/articles/s41564-024-01831-6
Dietary components of relevance to diet-microbiota associations in gastrointestinal research	Duncanson K et al. Diet-microbiota associations in gastrointestinal research: a systematic review. Gut Microbes. 2024;16(1):2350785	https://www.tandfonline.com/doi/full/10.1080/19490976.2024.2350785
Study design for research investigating diet-microbiome interactions	Shanahan ER, McMaster JJ, Staudacher HM. Conducting research on diet-microbiome interactions: A review of current challenges, essential methodological principles, and recommendations for best practice in study design. J Hum Nutr Diet. 2021; 34(4): 631-644.	https://onlinelibrary.wiley.com/doi/10.1111/jhn.12868

	Measuring mechanisms and endpoints in diet and nutrition studies in DGBI
Considerations for measuring gastrointestinal tract physiology in diet research	Biesiekierski JR, Yao C, Tuck C, Snelson M. Methodological advances in gastrointestinal tract physiology measurements: relevance to nutritional studies. Proceedings of the Nutrition Society. Published online 2024:1-36.	https://www.cambridge.org/core/journals/proceedings-of-the-nutrition-society/article/methodological-advances-in-gastrointestinal-tract-physiology-measurements-relevance-to-nutritional-studies/69902C0CAE8A113C5879FCC0ADD39DB2
Considerations for study design investigating dietary biomarkers	Cuparencu, C., Bulmuş-Tüccar, T., Stanstrup, J. et al. Towards nutrition with precision: unlocking biomarkers as dietary assessment tools. Nat Metab. 2024. 6, 1438–1453	https://doi.org/10.1038/s42255-024-01067-y  https://www.sciencedirect.com/science/article/pii/S2475299122129896

Preclinical study considerations in diet and DGBI research
Considerations for nutritional profile of rodent diets in microbiome research	Tuck, C.J., De Palma, G., Takami, K. et al. Nutritional profile of rodent diets impacts experimental reproducibility in microbiome preclinical research. Sci Rep 10, 17784 (2020).	https://www.nature.com/articles/s41598-020-74460-8#citeas https://www.cambridge.org/core/journals/proceedings-of-the-nutrition-society/article/methodological-advances-in-gastrointestinal-tract-physiology-measurements-relevance-to-nutritional-studies/69902C0CAE8A113C5879FCC0ADD39DB2
Sex dependent considerations for chow provision in mice studies	Valiauga R, Talley S, Khemmani M et al. Sex-dependent effects of carbohydrate source and quantity on caspase-1 activity in the mouse central nervous system. J Neuroinflammation. 2024 5;21(1):151	https://jneuroinflammation.biomedcentral.com/articles/10.1186/s12974-024-03140-5 https://doi.org/10.1038/s42255-024-01067-y  https://www.sciencedirect.com/science/article/pii/S2475299122129896
Considerations for chow-dependent variability in dietary intake and microbiome	Zaparte A, Dore E, White S, et al. Standard rodent diets differentially impact alcohol consumption and preference and gut microbiome diversity. Front Neurosci. 2024 13;18:1383181	Zaparte A, Dore E, White S, et al. Standard rodent diets differentially impact alcohol consumption and preference and gut microbiome diversity. Front Neurosci. 2024 13;18:1383181 https://www.frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1383181/full https://jneuroinflammation.biomedcentral.com/articles/10.1186/s12974-024-03140-5 https://doi.org/10.1038/s42255-024-01067-y  https://www.sciencedirect.com/science/article/pii/S2475299122129896

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