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Listen to our latest Rome Diet and Nutrition Section Podcast

Listen to our latest Rome Diet and Nutrition Section Podcast

Dr. Prashant Singh and Karen Routhiaux sit with Dr. Madison Simons to discuss the simple low FODMAP diet. Listen now to learn more about the methodology of recently published dietary trials.

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 designReference
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.
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.
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.
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.
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
Microbiome, probiotic and prebiotic trial design Reference
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
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.
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.
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.
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.
Measuring mechanisms and endpoints in diet and nutrition studies in DGBI Reference
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.
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). 
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. 
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.
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
Preclinical study considerations in diet and DGBI research Reference
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).
Sex dependent considerations for chow provision in mice studies Sex-dependent effects of carbohydrate source and quantity on caspase-1 activity in the mouse central nervous system

Considerations for chow-dependent variability in dietary intake and microbiome Standard rodent diets differentially impact alcohol consumption, preference, and gut microbiome diversity
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