If not recorded, it won’t happen: US documentation and regulation of randomized controlled trials of human nutrition
Current training in human research emphasizes drugs and devices, while encouraging dependence on monitoring boards. Human nutrition experiments have unique characteristics that should be considered. However, training and research monitoring in human nutrition research is lacking, and best practices have not been developed and collected in one place. In human feeding research, under free living conditions, risks related to food consumption are not easy to distinguish risks. Under free living conditions, there is a risk of suffocation, vomiting, vomiting, etc. in common diet and drinking activities. Often, there is insufficient need for the importance of documentation and compliance with regulations imposed by sponsors, agencies and regulators when training for nutrition scientists and planning and conducting research.
: : : : : : : : : : : : : : : This article is one of a series of five articles outlining the core principles of design, conduct and reporting of randomized controlled trials of human nutrition. All five papers are published Nutritional progress.
Dietary guidance should be based on the strongest evidence base. This article provides best practices for documenting and compliance with regulations. Other articles in the series cover best practices in designing, conducting and analyzing rigorous human nutrition research. ” Professor Weaver said.
According to the paper, managing the randomized controlled trial of human nutrition (RCT) puts researchers, participants, and institutions in a position of great responsibility and vulnerability. Multiple steps must be navigated to protect all parties and guidelines. Nevertheless, these principles allow researchers to see whether diet affects food/healthy relationships.
In addition to definitions, the authors provide guidance on the regulation of clinical nutrition research related to regulatory committees, participant safety, stakeholder training; local cultural and reporting requirements related to diet-related clinical research behaviors and documentation.
Weaver and colleagues advise that knowledge and experience assessing the dietary safety and behavior of the population in the study are relevant expertise when forming a research monitoring agency. Furthermore, the difference between diet-related adverse reactions to interventions and non-intervention events (e.g., participant behavior) needs to be paid attention to in planning, conducting and monitoring studies. Finally, standard diet-related operating protocols should be included in researcher and staff training. Professor Weaver added: “Developing standard operational protocols can help meet documentation requirements and conduct high-quality research.”
The authors reviewed a good documentation procedure and a multifaceted regulatory environment, including examples related to human nutrition RCT. The main focus of this article is on the specific situations encountered in human nutrition RCT (examples), although many of the topics covered in this article apply to a variety of clinical research areas.
Journal Reference:
Weaver CM, Fukagawa NK, Liska D, Mattes RD, Matuszek G, Nieves JW, Shapses SA, Snetselaar LG. Viewpoint: Documentation and regulation of randomized controlled trials of human nutrition in the United States. Adv Nutr 2020, 12 (1) 21-45, doi: 10.1093, 2021. https://doi.org/10.1093/advances/nmaa118
About the Author
Outstanding Professor Emerita Dr. Connie M. Weaver
Dr. Weaver is an outstanding professor of nutrition science at Purdue University in Indiana and CEO of Weaver and Associates Consulting, LLC. She has been an elected member of the National College of Science, Engineering and Medicine since 2010. She is a fellow at the American Nutrition Society, School of Food Technology, American Nutrition, American Heart Association and American Society for Bone and Mineral Research. She is a predecessor Member of the ILSI GC Board of Directors and the FDA’s Scientific Advisory Committee, the California Walnut Board of Directors and the FORCE FOR BOTER HEALTH (PBH) Foundation. Dr. Weaver is the former president of the American Society for Nutritional Sciences. : : : : : : : : : : : : : : : Dr. Weaver received his bachelor’s and master’s and doctoral degrees from Oregon State University. Food Science and Human Nutrition from Florida State University.
