Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: Guidelines from the International Society for Nutritional Psychiatry Research

Wolfgang Marx¹, Marjolein Visser^{2

3}, Caroline Wallace⁴, Felice N Jacka¹, Jessica Bayes⁵, Heather Francis^{6

7}, Rachelle Opie⁸, Meghan Hockey¹, Scott B Teasdale⁹, Almudena Sanchez Villegas^{10

11}, Adrienne O'Neil¹, Kuan-Pin Su^{12

13}, Julia J Rucklidge¹⁴, Michael Berk¹, Adrian Lopresti¹⁵, David Mischoulon¹⁶, Jeanette M Johnstone¹⁷, Heidi M Staudacher¹

Affiliations

¹ Deakin University, Institute for Mental and Physical Health and Clinical Translation (IMPACT), Food & Mood Centre, School of Medicine, Geelong, VIC, Australia.
² Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
³ Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
⁴ School of Nutrition Sciences, University of Ottawa, Ottawa, ON, Canada.
⁵ Faculty of Health, Southern Cross University, East Lismore, NSW, Australia.
⁶ School of Psychological Sciences, Macquarie University, Sydney, Australia.
⁷ Neurology Department, Royal North Shore Hospital, Sydney, Australia.
⁸ Food for Thought Nutrition and Dietetics, Burwood, VIC, Australia.
⁹ Discipline of Psychiatry and Mental Health, School of Clinical Medicine, UNSW Sydney, Kensington, NSW, Australia.
¹⁰ Biomedical Research Center Network on Physiopathology of Obesity and Nutrition (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.
¹¹ ISFOOD - Institute for Innovation & Sustainable Development in Food Chain, Universidad Pública de Navarra (UPNA), Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
¹² Mind-Body Interface Research Center (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.
¹³ An-Nan Hospital, China Medical University, Tainan, Taiwan.
¹⁴ School of Psychology, Speech and Hearing, University of Canterbury, Christchurch, New Zealand.
¹⁵ Clinical Research Australia, Perth, WA, Australia.
¹⁶ Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
¹⁷ Oregon Health & Science University, Center for Mental Health Innovation, Department of Psychiatry, Portland, Oregon, USA.

PMID: 39654150
PMCID: PMC12269743
DOI: 10.1017/S0007114524001946

Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: Guidelines from the International Society for Nutritional Psychiatry Research

Wolfgang Marx et al. Br J Nutr. 2024.

. 2024 Dec 10:1-13.

doi: 10.1017/S0007114524001946. Online ahead of print.

Authors

Affiliations

¹ Deakin University, Institute for Mental and Physical Health and Clinical Translation (IMPACT), Food & Mood Centre, School of Medicine, Geelong, VIC, Australia.
² Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
³ Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
⁴ School of Nutrition Sciences, University of Ottawa, Ottawa, ON, Canada.
⁵ Faculty of Health, Southern Cross University, East Lismore, NSW, Australia.
⁶ School of Psychological Sciences, Macquarie University, Sydney, Australia.
⁷ Neurology Department, Royal North Shore Hospital, Sydney, Australia.
⁸ Food for Thought Nutrition and Dietetics, Burwood, VIC, Australia.
⁹ Discipline of Psychiatry and Mental Health, School of Clinical Medicine, UNSW Sydney, Kensington, NSW, Australia.
¹⁰ Biomedical Research Center Network on Physiopathology of Obesity and Nutrition (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.
¹¹ ISFOOD - Institute for Innovation & Sustainable Development in Food Chain, Universidad Pública de Navarra (UPNA), Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
¹² Mind-Body Interface Research Center (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.
¹³ An-Nan Hospital, China Medical University, Tainan, Taiwan.
¹⁴ School of Psychology, Speech and Hearing, University of Canterbury, Christchurch, New Zealand.
¹⁵ Clinical Research Australia, Perth, WA, Australia.
¹⁶ Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
¹⁷ Oregon Health & Science University, Center for Mental Health Innovation, Department of Psychiatry, Portland, Oregon, USA.

PMID: 39654150
PMCID: PMC12269743
DOI: 10.1017/S0007114524001946

Abstract

Research on nutraceutical and dietary interventions in psychiatry has grown substantially, but progress is hindered by methodological inconsistencies and limited reporting standards. To address this, the International Society for Nutritional Psychiatry Research presents the first guidelines on clinical trial design, conduct, and reporting for future clinical trials in this area. Recommendations were developed using a Delphi process including eighteen researchers with considerable clinical trial expertise and experience in either methodology, nutraceutical, or dietary interventions in psychiatry. These guidelines provide forty-nine recommendations for clinical trial design and outcomes, five for trial reporting, and seven for future research priorities. The recommendations included in these guidelines are designed to inform both nutraceutical and dietary clinical trial interventions in Nutritional Psychiatry. Common themes include an emphasis on the importance of a multidisciplinary research team and integration of co-design processes into the conduct and design of clinical research, methods to improve transparency and replicability of trial outcomes, and measures to address common biases in nutrition trials. Furthermore, we provide recommendations for future research including examining a greater variety of nutraceutical and dietary interventions, scalable delivery models, effectiveness and implementation studies, and the need to investigate these interventions in the prevention and management of less studied psychiatric conditions (e.g. schizophrenia and bipolar disorder). Recommendations included within these guidelines are intended to improve the rigor and clinical relevance of ongoing and future clinical trials in Nutritional Psychiatry.

Keywords: Clinical trials; Guidelines; Mental health; Nutritional psychiatry.

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Conflict of interest statement

Due to the reported risk of bias associated with industry funding in medicine⁽⁷⁵⁾, our guidelines provide strong endorsement for the need to clearly report industry funding and degree of involvement in all aspects of the clinical trial, data analysis and interpretation, and manuscript development. Resources such as the recently published Food Research risK (FoRK) toolkit⁽⁷⁶⁾ may provide a structured framework to navigate these issues. Furthermore, when declaring conflicts of interests, authors are encouraged to err on the side of full disclosure, thereby allowing readers to assess the potential effect of any disclosed conflicts on the research outcomes.

Figures

**Figure 1.**
Guidelines development process.

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Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: Guidelines from the International Society for Nutritional Psychiatry Research

Affiliations

Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: Guidelines from the International Society for Nutritional Psychiatry Research

Authors

Affiliations

Abstract

Conflict of interest statement

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