Dietary Crossover Trials: Validity Concerns Addressed

Ioannidis, J. P. A. The challenge of reforming nutritional epidemiologic research. JAMA 320969–970 (2018).

PubMed

Google Scholar

Hall, K. D., Guo, J. & Speakman, J. R. Do low-carbohydrate diets increase energy expenditure? Int. J. Obes. 432350–2354 (2019).

Google Scholar

Dhurandhar, N. V. et al. Energy balance measurement: when something is not better than nothing. Int. J. Obes. 391109–1113 (2014).

Google Scholar

Bajunaid, R. et al. Predictive equation derived from 6,497 doubly labelled water measurements enables the detection of erroneous self-reported energy intake. Nat. Food 658–71 (2025).

CAS
PubMed
PubMed Central

Google Scholar

Hall, K. D. et al. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Night. With. 27344–353 (2021).

CAS
PubMed

Google Scholar

Ludwig, D. S., Putt, M. E. & Willett, W. Matters arising: concern for the validity of short-term dietary crossover trials. Night. With. https://doi.org/10.1038/s41591-025-03909-y (2025).

Ludwig, D. S. et al. The carbohydrate–insulin model: a physiological perspective on the obesity pandemic. Am. J. Clin. Nutr. 1141873–1885 (2021).

CAS
PubMed
PubMed Central

Google Scholar

Goldacre, B. Make journals report clinical trials properly. Nature 5307 (2016).

CAS
PubMed

Google Scholar

Senn, SS Statistical Issues in Drug Development, 3rd Edition (John Wiley & Sons, 2021).

Sciarrillo, C. M., Guo, J., Hengist, A., Darcey, V. L. & Hall, K. D. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am. J. Clin. Nutr. 120953–963 (2024).

CAS
PubMed
PubMed Central

Google Scholar

Sciarrillo, C. M., Guo, J., Hengist, A., Darcey, V. L. & Hall, K. D. Flawed reanalysis fails to support the carbohydrate–insulin model of obesity. J. Nutr. 1541058–1060 (2024).

CAS
PubMed
PubMed Central

Google Scholar

Soto-Mota, A. et al. Physiologic adaptation to macronutrient change distorts findings from short dietary trials: reanalysis of a metabolic ward study. J. Nutr. 1541080–1086 (2024).

CAS
PubMed

Google Scholar

Senn, S. Viewpoint: do not resurrect the two-stage procedure. Pharm. Stat. 21808–814 (2022).

PubMed

Google Scholar

Freeman, P. R. The performance of the two-stage analysis of two-treatment, two-period crossover trials. State. With. 81421–1432 (1989).

CAS
PubMed

Google Scholar

Hall, K. D. Challenges of human nutrition research. Science 3671298–1300 (2020).

CAS
PubMed

Google Scholar