Abstract
Intervention studies in humans provide the highest level of evidence in the assessment of the effect of nutrients or bioactive food components on human health /disease. There are different intervention study designs, and their selection depends on the objectives of the study. Here we present the main designs and the factors that should be considered when selecting and developing them.
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Reglament EU 1924/2006 Of the European Parliament and of the council of 20 December 2006 on nutrition and health claims made on foods. https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924.
Commission regulation (EC). No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council
European Commission Nutrition and health claims. https://ec.europa.eu/food/safety/labelling_nutrition/claims_en. In: .
USDA/HHS commitment to evidence-based process. http://www.nel.gov/default.cfm?library=DGAC.
Bohn T, McDougall G, Alegría A, Alminger M, Arrigoni E, Aura A, Brito C, Cilla A, El SN, Karakaya S, Martínez-Cuesta MC, Santos CN (2015) Mind the gap-deficits in our knowledge of aspects impacting the bioavailability of phytochemicals and their metabolites—a position paper focusing on carotenoids and polyphenols. Mol Nutr Food Res 59:1307–1323
Granado F, Olmedilla B, Herrero C, Pérez-Sacristán B, Blanco I, Blázquez S (2006) Bioavailability of carotenoids and tocopherols from broccoli: in vivo and in vitro assessment. Exp Biol Med 231(11):1733–1738
Granado-Lorencio F, Olmedilla-Alonso B, Herrero-Barbudo C, Pérez-Sacristán B, Blanco-Navarro I, Blázquez-García S (2007) Comparative in vitro bioaccesibility of carotenoids from relevant contributors to carotenoid intake. J Agric Food Chem 55(15):6387–6394
Rodríguez-Concepción M, Avalos J, Bonet ML, Boronat A, Gomez-Gomez L, Hornero-Mendez D, Limon MC, Meléndez-Martínez AJ, Olmedilla-Alonso B, Palou A, Ribot J, Rodrigo MJ, Zacarias L, Zhu C (2018) A global perspective on carotenoids: metabolism, biotechnology, and benefits for nutrition and health. Prog Lipid Res 70:62–93
Sheftel J, Loechl C, Mokhtar N, Tanumihardjo SA (2018) Use of stable isotopes to evaluate bioefficacy of provitamin a carotenoids, vitamin a status, and bioavailability of iron and zinc. Adv Nutr 9:625–636
USDA Food Composition Databases. United States Department of Agriculture Agricultural Research Service. https://ndb.nal.usda.gov/ndb/nutrients/index.
Dias MG, Olmedilla-Alonso B, Hornero-Méndez D, Mercadante AZ, Osorio C, Vargas-Murga L, Meléndez-Martínez AJ (2018) Comprehensive database of carotenoid contents in ibero-american foods. A valuable tool in the context of functional foods and the establishment of recommended intakes of bioactives. J Agric Food Chem 66:5055–5107
WMA (World Medical Association) (2013) Declaration of Helsinki—Ethical principles for medical research involving human subjects. . https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Council of Europe Convention on Human Rights and Biomedicine. https://www.coe.int/el/web/portal/full-news/-/asset_publisher/Dgh51iCGvfbg/content/the-convention-on-human-rights-and-biomedicine-celebrates-its-20th-anniversary.
UNESCO’s Universal Declaration on the Human Genome and Human Rights. http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/.
Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32016R0679.
Council of Europe (2016) Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin. . https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff
Aggett P, Antonine JM, de Vries J, Gallagher A, Hendriks H, Kozianowski G, Meijer G, Richardson D, Rondeau V, Tweedie G, Welch R, Wittwer J (2010) Beyond PASSCLAIM—Guidance to substantiate health claims on foods. In Ates K (ed). ILSI Eur Report Series, 7–19
Welch RW, Antonine JM, Berta JL, Bub A, De VJ, Guarner F, Hasselwander FF, Jäkel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Wodside JV (2011) Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr 106(2):S3–S15
Lucey A, Heneghan C, Kiely ME (2016) Guidance for the design and implementation of human dietary intervention studies for health claim submissions. Nutr Bull 41:378–394
USDA-NIH (2018). https://www.nia.nih.gov/research/grants-funding/implementation-policies-human-intervention-studies.
CONSORT (Consolidated Standards of Reporting Trials). www.consort-statement.org
Deeks JJ, Dinnes J, D’Amico R, Sowden AJ, Sakarovitch C, Song F, Petticrew M, Altman DG (2003) Evaluating non-randomised intervention studies. Health Technol Assesess 7(27)
Hawkes C (2004) Nutrition labels and health claims: the global regulatory environment. WHO
Combs GF, Trumbo PR, McKinley MC, Milner J, Studenski S, Kimura T, Watkins SM, Raiten DJ (2013) Biomarkers in nutrition: new frontiers in research and application. Ann N Y Acad Sci 1278:1–10
Granado-Lorencio F, Blanco-Navarro I, Pérez-Sacristán B, Hernández-Álvarez E (2017) Biomarkers of carotenoid bioavailability. Food Res Int 99:902–916
Rutishauser IHE, Black AE (2002) Introducción a la Nutrición Humana. In: Nutr Soc
Granado-Lorencio F, Olmedilla-Alonso B (2003) Bioavailability of vitamins. In: Vaquero MP, García-Arias T, Carbajal A, Sánchez-Muñiz FJ (eds) Bioavailability of micronutrients and minor dietary compounds. Metabolic and technological aspets.. Rec Res Dev Nutr. Research Signpost, Kerala, India, pp 19–30
Tang G (2010) Bioconversion of dietary provitamin A carotenoids to vitamin A in humans. Am J Clin Nutr 91(suppl):1468S–1473S
Britton G, Khachik F (2009) Carotenoids in food. In: Carotenoids, vol. 5, chapter 3. Birkhäuser Verlag Basel
Acknowledgments
Spanish Carotenoid Network (CaRed) funded by the Spanish MINECO (Ministry of Economy, Industry and Competitiveness) grants BIO2015-71703-REDT and BIO2017-90877-REDT, the European Carotenoid Network (EuroCaroten) funded by the European Commission COST Action CA15136 and Instituto de Salud Carlos III-ERDF grant PI16/01991.
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Olmedilla-Alonso, B. (2020). Intervention Studies in Humans. In: Rodríguez-Concepción, M., Welsch, R. (eds) Plant and Food Carotenoids. Methods in Molecular Biology, vol 2083. Humana, New York, NY. https://doi.org/10.1007/978-1-4939-9952-1_27
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DOI: https://doi.org/10.1007/978-1-4939-9952-1_27
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