Clinical Research in Nutrition

Objectives

To know the general principles of a healthy eating pattern and the dietary recommendations for different macro- and micronutrients; To understand the complexity of the food matrix; To know the role of diet in evolution and complications, prevention and treatment of chronic noncommunicable diseases; To know the Clinical Nutrition Law; To be able to design a clinical intervention study; To be able to analyze the results of an intervention study; To know the ethical and deontological particularities of clinical nutrition studies.

General characterization

Code

191009

Credits

Responsible teacher

Prof.ª Doutora Maria da Conceição Costa Pinho Calhau

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese or English

Prerequisites

Bibliography

Websites:

http://www.consulai.com/newsletter/07/pdf/R_CE_353_2008.pdf

https://dre.pt/application/dir/pdf1s/2014/04/07500/0245002465.pdf

Livros de referência:

· Asp, N.G. & Bryngelsson, S. (2008). Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr. 138(6):1210S-5S.

· Flynn, A. (2012). Scientific substantiation of health claims in the EU. Proc Nutr Soc. 71(1):120-6.

· Gallagher, A.M., Meijer, G.W., Richardson, D.P., Rondeau, V., Skarp, M., Stasse-Wolthuis, M., Tweedie, G.C., Witkamp, R. & International Life Sciences Institute Europe Functional Foods Task Force. (2011). A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance. Br J Nutr. 106 Suppl 2:S16-28.

· Welch, R.W., Antoine, J.M., Berta, J.L., Bub, A., de Vries, J. Guarner, F., Hasselwander, O., Hendriks, H., Jäkel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Woodside J.V. & International Life Sciences Institute Europe Functional Foods Task Force (2011). Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 106 Suppl 2:S3-15. doi: 10.1017/S0007114511003606.

· Woodside, J.V., Koletzko, B.V., Patterson, C.C. & Welch, R.W. (2013). Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescentes. World Rev Nutr Diet. 108:18-31. doi: 10.1159/000351481.

Teaching method

Theoretical classes; Seminars; Tutorial orientation.

Evaluation method

Evaluation: Distributed evaluation with final work presentation.

Frequency: Participation in at least 75% of teaching hours.

Subject matter

· General notions of Human Food and Nutrition;

· General notions of the role of nutrition on chronic diseases: prevention and therapy;

· Notion of biokinetic and bioactivity;

· Complexity of the food matrix. Notions of 'functional foods',' nutraceutical 'and' food supplement';

· Interactions food-drugs;

· Presentation and discussion of LIC (Clinical Research Law). Peculiarities in clinical studies of Nutrition;

· European regulations for nutritional and health claims;

· Design of clinical studies in nutrition: leges artis. Special features of experimental design (intervention studies and observation);

· Ethical and deontological peculiarities in these studies;

· Trial registration. Documents required for ethical approval by the competent Ethics Committee;

· Clinical studies and Data Protection National Commission.

Programs

Programs where the course is taught:

Master in Clinical Research Management