By Invitation only

If you are interested in being considered as an attendee to this workshop, please contact info@cns-scn.ca

Best Practices for Randomized Controlled Clinical Studies on the Effects of Whole Foods 


Date: Thursday, December 5, 2019
Location: Hilton Garden Inn Downtown, Ottawa, ON
By Invitation Only

Workshop Objectives

 

THURSDAY, DECEMBER 5, 2019
Hilton Garden Inn Downtown, Ottawa ON
08:00 - 08:30  Registration: Coffee and Light Breakfast
08:45 - 9:00 Introduction to Workshop
  • Framing of the Workshop and Objectives
  • Why Now
Speaker: James House, PhD - University of Manitoba
expand bio +/-

About the speaker:

Dr. House received his B.Sc. (Agr) from the University of Guelph in 1990. He then completed his Ph.D. in nutrition and metabolism from the Department of Animal & Poultry Science at the University of Guelph in 1996, under the co-supervision of Drs. Ron Ball and Paul Pencharz. For the next three years, Jim worked as a post-doctoral fellow in the Department of Biochemistry at Memorial University of Newfoundland in St. John's, with Dr. Sean Brosnan, where he was the recipient of a Medical Research Council of Canada Fellowship in 1998. In the fall of 1998, he joined the Department of Animal Science at the University of Manitoba, with a cross-appointment to the Department of Human Nutritional Sciences. Jim has received the young investigator awards from Canadian Society of Animal Science (CSAS) and the Canadian Society for Nutritional Sciences. He has been active in the Canadian nutrition community, serving a 3-year term as awards councilor for the Canadian Society for Nutritional Sciences (CSNS), and chairing the joint meeting of CSNS, CSAS, and the Canadian Section of the American Oil Chemists' Society (CAOCS), officially known as the Canadian Nutrition Congress, in Winnipeg in 2007. With respect to his research program, his current interests include understanding the interplay between vitamin status and amino acid metabolism and the investigation of factors influencing the nutritional quality of eggs. In January 2009, Jim was appointed Head of the Department of Human Nutritional Sciences, University of Manitoba.

09:00 - 09:30 Optimizing the design of human clinical trials
Speaker: George A. Wells, MSc, PhD - University of Ottawa Heart Institute
expand abstract and bio +/-

Description:

To Come 

About the Speaker:

George A. Wells, MSc, PhD
Professor, School of Epidemiology and Public Health, University of Ottawa
Professor, Department of Medicine, University of Ottawa
Principal Investigator, Cardiovascular Research Methods Centre, University of Ottawa
Heart Institute

Dr. Wells is a Professor in the School of Epidemiology and Public Health at the University of Ottawa and Principal Investigator of the Cardiovascular Research Methods Centre at the University of Ottawa Heart Institute. He is also a Professor in the Department of Medicine and a Senior Investigator at the Ottawa Hospital Research Institute at the Ottawa Hospital. His research interests are in the design and analysis of clinical trials, health technology assessment, statistical methodology related to health care delivery, systematic reviews andmeta-analysis, economic evaluations and the development and assessment of decision support technologies for patients and practitioners. Dr. Wells is the author or co-author of over 900 published articles and over 1050 scientific abstracts. He has been the principal investigator or co-investigator on over 270 research projects. His H-index score in Google Scholar is 174 and Scopus 134 and Web of Science 152. He has taught at the University graduate and undergraduate level for 40 years and has supervised over 100 graduate students.
Dr. Wells has worked extensively with national and international government and nongovernment research organizations, as well as private pharmaceutical and biotechnology industries. He has been on the executive and steering committees of national and international research programs, external safety and efficacy monitoring committees, scientific grant review committees, editorial committees and, scientific advisory committees. He is currently an Associate Editor of the Journal of Clinical Epidemiology and on the Editorial Committee of the Canadian Medical Association Journal.

09:30 - 10:00 Overview of the issues/challenges related to Clinical Trials among Whole foods
Speaker: Benoît Lamarche, PhD - Université Laval
expand abstract and bio +/-

Description:

Evaluating the health benefits of foods is not without challenges in nutrition-oriented randomized clinical trials (RCT). The degree of certainty of this evaluation is dependent, among others, on the quality and reproducibility of the clinical trial data, which hinge on the design and implementation of the integrity of such RCT. Currently limited resources and guidelines are available for identifying the various steps involved in a nutrition-oriented RCT. This presentation will identify the many challenges that face researchers when designing and undertaking research to test the effect of foods on health and will propose some avenues and solutions to address these challenges.

About the Speaker:

Dr. Benoît Lamarche is Full Professor at the School of Nutrition and Chair of Nutrition at Laval University. He is the Scientific Director of the FRQS-funded Research Center on Nutrition, Health and Society (NUTRISS). He is also the Scientific Director of PULSAR, an interdisciplinary research platform comprising more than 200 researchers dedicated to the study of sustainable health at Laval University. He has published more than 365 peer-reviewed papers on physiological, clinical, epidemiological and public health issues related to food and health. He has contributed the training of more than 60 MSc, PhD students and postdocs. He has received numerous awards, including awards from the Société Québécoise de lipidologie, nutrition et métabolisme (Prix des Fondateurs, 2013) and the Canadian Nutrition Society (Centrum New Investigator Award, 2011). He has co-written two books with the acclaimed Chef Jean Soulard on the topics of nutrition, sport and health. Benoît Lamarche is an Olympian (1984, 1988) in long track speed skating.

10:00 - 10:30 

Health Claims and their Substantiation – Overview of the steps and requirements
- Case study as an example of challenges faced in food trials
Speaker: Kathy Musa-Veloso, PhD - Intertek

expand abstract and bio +/-

Description:

Diet is recognized as having an instrumental role in the maintenance of health and prevention of disease.  To further our understanding of the importance of the foods we eat, it is important to be able to study the health benefits of foods.  The randomized controlled trial (RCT) paradigm, originally developed for the clinical study of pharmaceuticals, has also been applied to the clinical study of whole foods.  The problem, however, is that clinical studies of whole foods are associated with unique challenges.  In my presentation, I will provide an overview of the substantiation requirements for food health claims in Canada and will use clinical studies conducted on a whole food (i.e., almonds) to illustrate the challenges inherent in designing and interpreting the results of these studies.  

About the Speaker:

Dr. Kathy Musa-Veloso is the Senior Director of the Health Claims and Clinical Trials group within Intertek Health Sciences Inc.  With a focus on the health benefits of foods and food ingredients, Dr. Musa-Veloso and her team of scientific and regulatory consultants play an active role in the development of clinical trial protocols, as well as the preparation and stewardship of health claim applications in key markets globally, including Canada, the United States, the European Union, and Australia/New Zealand.  Dr. Musa-Veloso has published systematic, evidence-based reviews and meta-analyses on the efficacy of foods and food ingredients in improving health.  She is a recognized expert on global scientific and regulatory requirements for health claim substantiation, and has been invited as a guest speaker to several conferences and symposia, both domestically and internationally.  Having completed a combined Honours B.Sc. degree in Kinesiology and Health Science at York University, Dr. Musa-Veloso went on to receive her M.Sc. and Ph.D. from the Department of Nutritional Sciences at the University of Toronto, where Dr. Musa-Veloso currently serves as an Adjunct Professor.

10:30 - 10:45 Health Break
10:45 - 11:15  Best Practices for Randomized Controlled Clinical Studies on the Effects of Whole Foods: An FDA Perspective
Speaker: Paula R. Trumbo PhD, Adjunct Faculty, Department of Food Science and Nutrition, University of Minnesota
expand abstract and bio +/-

Description:

FDA conducts the premarket review of health claims on the relationship between a food or food component and a disease or health-related condition. Guidance to industry is available on the substantiation of health claims and outlines the various factors that the agency considers when reviewing the available scientific evidence.  Evidence that would not be considered to support a health claim for a food would be data on dietary patterns and data on a specific component of the food of interest. An important consideration when evaluating the evidence for a food is whether the effect on a disease or health-related condition is a result of adding the food to a diet or substitution of a food(s) with the food that is subject of the health claim. This consideration determines the type of control group and bias that must be evaluated to determine if scientific conclusions can be drawn from such evidence and the quality of the evidence. If sufficient evidence is available, the agency identifies an effective dose for the relationship that can be provided in the claim language for food labeling.

About the Speaker:

Paula R. Trumbo, PhD is an independent consultant to industry on various nutrition science and regulatory issues. She retired from the FDA in 2018. At FDA, she led the Nutrition Science Review Team that is responsible for the pre-market review of the scientific evidence for food labeling, including health claims, meeting the definition of dietary fiber, and amendments to the Nutrition and Supplement Fact label regulations. She was the US delegate to the Codex Committee on Nutrition and Foods for Special Dietary Uses. Prior to joining the FDA, Dr. Trumbo served as Study Director for a number of study panels at the National Academy of Science/Institute of Medicine’s Food and Nutrition Board and was Associate Professor of Nutrition at Purdue University. Dr. Trumbo has a PhD in biochemistry with minor in nutrition.

11:15 - 11:45 Publishing Results from Clinical Studies with Whole Foods – Insights from a Journal Editor
Speaker: Dennis Bier, M.D - Baylor College of Medicine
expand abstract and bio +/-

Description:

Coming Soon

About the Speaker:

Coming Soon

11:45 - 12:00 Summary of morning sessions and goals for the afternoon
12:00 - 13:00 
Lunch
13:00 - 13:45 Breakout – Review of Chronic Case Study/Clinical Trial Protocol (Lipid Lowering as outcome variable)
13:45 - 14:30 Report Back / Discussion
14:30 - 14:45 Health Break
14:45 - 15:30 Breakout – Acute Case Study/Clinical Trial Protocol (Satiety as outcome variable)
15:30 - 16:15 Report Back / Discussion
16:15 - 16:30 Next Steps for Establishing Best Practices & Concluding Remarks
 
Thanks to our workshop partner
 
Thanks to our funder

 

 


© 2019 CNS-SCN - Canadian Nutrition Society
^