Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

ACC 2024 Congress

Catch up on all the top stories and latest evidence in cardiology research with our ACC 2024 Congress hub page.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Review

Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

Authors: Martine Laville, Berenice Segrestin, Maud Alligier, Cristina Ruano-Rodríguez, Lluis Serra-Majem, Michael Hiesmayr, Annemie Schols, Carlo La Vecchia, Yves Boirie, Ana Rath, Edmund A. M. Neugebauer, Silvio Garattini, Vittorio Bertele, Christine Kubiak, Jacques Demotes-Mainard, Janus C. Jakobsen, Snezana Djurisic, Christian Gluud

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Evidence-based clinical research poses special barriers in the field of nutrition. The present review summarises the main barriers to research in the field of nutrition that are not common to all randomised clinical trials or trials on rare diseases and highlights opportunities for improvements.

Methods

Systematic academic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.

Results

Many nutrients occur in multiple forms that differ in biological activity, and several factors can alter their bioavailability which raises barriers to their assessment. These include specific difficulties with blinding procedures, with assessments of dietary intake, and with selecting appropriate outcomes as patient-centred outcomes may occur decennia into the future. The methodologies and regulations for drug trials are, however, applicable to nutrition trials.

Conclusions

Research on clinical nutrition should start by collecting clinical data systematically in databases and registries. Measurable patient-centred outcomes and appropriate study designs are needed. International cooperation and multistakeholder engagement are key for success.
Appendix
Available only for authorised users
Footnotes
1
Funded by the European Union Framework Programme 7 (EU FP7; grant agreement no. 284395), ECRIN-IA involved 23 countries and brought together diverse stakeholders to overcome barriers to clinical research in three particularly difficult areas (rare diseases, medical devices, and nutrition). Specifically, the project aimed to develop tools, services, and infrastructure to facilitate multinational clinical research in Europe, and to support the development of pan-European disease networks to drive clinical projects. This in turn was intended to improve Europe’s attractiveness to industry, boost its scientific competitiveness, and result in better health care for European citizens. Originally planned for 4 years (2012 to 2015), the clinical trials work package was extended until 2017.
 
Literature
1.
Garattini S, Jakobsen JC, Wetterslev J, Bertele V, Banzi R, Rath A, et al. Evidence-based clinical practice: overview of threats to the validity of evidence and how to minimise them. Eur J Intern Med. 2016;32:13–21. Epub 11 May 2016.CrossRefPubMed
2.
3.
Demotes-Mainard J, Kubiak C. A European perspective—the European Clinical Research Infrastructures Network. Ann Oncol. 2011;22(Suppl 7):vii 44–9. Epub 9 Nov 2011.
4.
Djurisic S, Rath A, Gaber S, Garattini S, Bertele V, Ngwabyt SN, et al. Barriers to the conduct of randomised clinical trials within all disease areas. Trials. 2017;18(1):360.CrossRefPubMedPubMedCentral
5.
Rath A, Salamon V, Peixoto S, Hivert V, Laville M, Masson Y, et al. A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome? Trials [accepted for publication]. 2017.
6.
Neugebauer EAM, Rath A, Antoine S-L, Eikermann M, Seidel D, Koenen C, et al. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials [accepted for publication]. 2017.
7.
Meunier N, Roth H, Ferrand L, Laville M, Cano N. La recherche clinique en nutrition—Méthodologie et réglementation des essais cliniques. Nutr Clin Metab. 2010;24:93–108.CrossRef
8.
Ioannidis JP. We need more randomized trials in nutrition—preferably large, long-term, and with negative results. Am J Clin Nutr. 2016;103(6):1385–6. Epub 6 May 2016.CrossRefPubMed
9.
Jakobsen JC, Gluud C. The necessity of randomized clinical trials. Br J Med Res. 2013;3(4):i 453–i 1468.
10.
Maki KC, Slavin JL, Rains TM, Kris-Etherton PM. Limitations of observational evidence: implications for evidence-based dietary recommendations. Adv Nutr. 2014;5(1):7–15. Epub 16 Jan 2014.CrossRefPubMedPubMedCentral
11.
Ioannidis JP. Implausible results in human nutrition research. BMJ. 2013;347:f6698. Epub 16 Nov 2013.CrossRefPubMed
12.
Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999;52(1):19–26. Epub 11 Feb 1999.CrossRefPubMed
13.
Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368(14):1279–90. Epub 26 Feb 2013.CrossRefPubMed
14.
Dominguez-Salas P, Moore SE, Cole D, da Costa KA, Cox SE, Dyer RA, et al. DNA methylation potential: dietary intake and blood concentrations of one-carbon metabolites and cofactors in rural African women. Am J Clin Nutr. 2013;97(6):1217–27. Epub 12 Apr 2013.CrossRefPubMedPubMedCentral
15.
Welch RW, Antoine JM, Berta JL, 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 JV. International Life Sciences Institute Europe Functional Foods Task Force guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 2011;106:3–15.CrossRef
16.
Salvador Castell G, Serra-Majem L, Ribas-Barba L. What and how much do we eat? 24-hour dietary recall method. Nutr Hosp. 2015;31 Suppl 3:46–8. Epub 27 Feb 2015.PubMed
17.
Poslusna K, Ruprich J, de Vries JH, Jakubikova M, van’t Veer P. Misreporting of energy and micronutrient intake estimated by food records and 24 hour recalls, control and adjustment methods in practice. Br J Nutr. 2009;101 Suppl 2:S73–85. Epub 15 Jul 2009.CrossRefPubMed
18.
19.
Illner AK, Freisling H, Boeing H, Huybrechts I, Crispim SP, Slimani N. Review and evaluation of innovative technologies for measuring diet in nutritional epidemiology. Int J Epidemiol. 2012;41(4):1187–203. Epub 31 Aug 2012.CrossRefPubMed
20.
Shriver BJ, Roman-Shriver CR, Long JD. Technology-based methods of dietary assessment: recent developments and considerations for clinical practice. Curr Opin Clin Nutr Metab Care. 2010;13(5):548–51. Epub 6 Jul 2010.CrossRefPubMed
21.
Hercberg S. Web-based studies: the future in nutritional epidemiology (and overarching epidemiology) for the benefit of public health? Prev Med. 2012;55(6):544–5. Epub 2012/09/27.CrossRefPubMed
22.
Majem LS, Bartrina JA. Nutricion y salud publica. Metodos, bases cientıficas y aplicaciones (Public Health Nutrition. Evidence base and applications). 2nd ed. Barcelona: Masson; 2006.
23.
Martin-Moreno JM, Gorgojo L. Valoración de la ingesta dietética a nivel poblacional mediante cuestionarios individuales: sombras y luces metodológicas. Rev Esp Salud Publica. 2007;81(5):507–18.CrossRefPubMed
24.
Hercberg S, Deheeger M, Preziosi P. SU-VI-MAX. Portions alimentaires. Manuel photos pour l’estimation des quantités. Paris: Poly Technica; 1994.
25.
Bach A, Serra-Majem L, Carrasco JL, Roman B, Ngo J, Bertomeu I, et al. The use of indexes evaluating the adherence to the Mediterranean diet in epidemiological studies: a review. Public Health Nutr. 2006;9(1A):132–46. Epub 4 Mar 2006.CrossRefPubMed
26.
Sanchez-Tainta A, Estruch R, Bullo M, Corella D, Gomez-Gracia E, Fiol M, et al. Adherence to a Mediterranean-type diet and reduced prevalence of clustered cardiovascular risk factors in a cohort of 3,204 high-risk patients. Eur J Cardiovasc Prev Rehabil. 2008;15(5):589–93. Epub 3 Oct 2008.CrossRefPubMed
27.
Alberti-Fidanza A, Fidanza F, Chiuchiu MP, Verducci G, Fruttini D. Dietary studies on two rural Italian population groups of the Seven Countries Study. 3. Trend of food and nutrient intake from 1960 to 1991. Eur J Clin Nutr. 1999;53(11):854–60. Epub 11 Nov 1999.CrossRefPubMed
28.
Trichopoulou A, Orfanos P, Norat T, Bueno-de-Mesquita B, Ocke MC, Peeters PH, et al. Modified Mediterranean diet and survival: EPIC-elderly prospective cohort study. BMJ. 2005;330(7498):991. Epub 12 Apr 2005.CrossRefPubMedPubMedCentral
29.
Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, et al. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004;7(7):931–5. Epub 16 Oct 2004.PubMed
30.
Trichopoulou A, Kouris-Blazos A, Wahlqvist ML, Gnardellis C, Lagiou P, Polychronopoulos E, et al. Diet and overall survival in elderly people. BMJ. 1995;311(7018):1457–60. Epub 2 Dec 1995.CrossRefPubMedPubMedCentral
31.
Martinez-Gonzalez MA, Garcia-Lopez M, Bes-Rastrollo M, Toledo E, Martinez-Lapiscina EH, Delgado-Rodriguez M, et al. Mediterranean diet and the incidence of cardiovascular disease: a Spanish cohort. Nutr Metab Cardiovasc Dis. 2011;21(4):237–44. Epub 26 Jan 2010.PubMed
32.
Mar Bibiloni M, Martinez E, Llull R, Maffiotte E, Riesco M, Llompart I, et al. Metabolic syndrome in adolescents in the Balearic Islands, a Mediterranean region. Nutr Metab Cardiovasc Dis. 2011;21(6):446–54. Epub 10 Mar 2010.CrossRefPubMed
33.
Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Marti A, Martinez JA, Martin-Moreno JM. Mediterranean diet and reduction in the risk of a first acute myocardial infarction: an operational healthy dietary score. Eur J Nutr. 2002;41(4):153–60. Epub 21 Sep 2002.CrossRefPubMed
34.
Buckland G, Agudo A, Lujan L, Jakszyn P, Bueno-de-Mesquita HB, Palli D, et al. Adherence to a Mediterranean diet and risk of gastric adenocarcinoma within the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort study. Am J Clin Nutr. 2010;91(2):381–90. Epub 17 Dec 2009.CrossRefPubMed
35.
La Vecchia C, Bosetti C. Diet and cancer risk in Mediterranean countries: open issues. Public Health Nutr. 2006;9(8A):1077–82. Epub 24 Mar 2007.CrossRefPubMed
36.
Toledo E, de A Carmona-Torre F, Alonso A, Puchau B, Zulet MA, Martinez JA, et al. Hypothesis-oriented food patterns and incidence of hypertension: 6-year follow-up of the SUN (Seguimiento Universidad de Navarra) prospective cohort. Public Health Nutr. 2010;13(3):338–49. Epub 7 Aug 2009.CrossRefPubMed
37.
Romaguera D, Norat T, Mouw T, May AM, Bamia C, Slimani N, et al. Adherence to the Mediterranean diet is associated with lower abdominal adiposity in European men and women. J Nutr. 2009;139(9):1728–37. Epub 3 Jul 2009.CrossRefPubMed
38.
Yannakoulia M, Panagiotakos D, Pitsavos C, Lentzas Y, Chrysohoou C, Skoumas I, et al. Five-year incidence of obesity and its determinants: the ATTICA study. Public Health Nutr. 2009;12(1):36–43. Epub 8 Mar 2008.CrossRefPubMed
39.
Martinez-Gonzalez MA, de la Fuente-Arrillaga C, Nunez-Cordoba JM, Basterra-Gortari FJ, Beunza JJ, Vazquez Z, et al. Adherence to Mediterranean diet and risk of developing diabetes: prospective cohort study. BMJ. 2008;336(7657):1348–51. Epub 31 May 2008.CrossRefPubMedPubMedCentral
40.
Brown TA. Confirmatory factor analysis for applied research. New York: Guilford Press; 2006.
41.
Hu FB. Dietary pattern analysis: a new direction in nutritional epidemiology. Curr Opin Lipidol. 2002;13(1):3–9. Epub 16 Jan 2002.CrossRefPubMed
42.
Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database Syst Rev. 2012;3:CD007176. Epub 16 Mar 2012.
43.
Feinberg J, Nielsen E, Korang S, Engell K, Rasmussen M, Zhang K, et al. OR29: nutrition support in hospitalised adults at nutritional risk. A Cochrane systematic review with meta-analysis and Trial Sequential Analysis (Abstract). Clin Nutr. 2016;35(1):S12.CrossRef
44.
Avenell A, Smith TO, Curtain JP, Mak JC, Myint PK. Nutritional supplementation for hip fracture aftercare in older people. Cochrane Database Syst Rev. 2016;11:CD001880. Epub 30 Nov 2016.PubMed
45.
Feinberg J, Nielsen EE, Gluud C, Lindschou J, Kondrup J, Jakobsen JC. Nutrition support in hospitalised adults at nutritional risk (Protocol). Cochrane Database Syst Rev. 2015(Issue 3):CD011598. doi:10.​1002/​14651858.​CD011598.
46.
Blumberg J, Heaney RP, Huncharek M, Scholl T, Stampfer M, Vieth R, et al. Evidence-based criteria in the nutritional context. Nutr Rev. 2010;68(8):478–84. Epub 22 Jul 2010.CrossRefPubMed
47.
Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, et al. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011;14(5):612–22. Epub 8 Nov 2011.CrossRefPubMed
48.
van Ommen B, Bouwman J, Dragsted LO, Drevon CA, Elliott R, de Groot P, et al. Challenges of molecular nutrition research 6: the nutritional phenotype database to store, share and evaluate nutritional systems biology studies. Genes Nutr. 2010;5(3):189–203. Epub 6 Nov 2010.CrossRefPubMedPubMedCentral
49.
Fagherazzi G, Vilier A, Saes Sartorelli D, Lajous M, Balkau B, Clavel-Chapelon F. Consumption of artificially and sugar-sweetened beverages and incident type 2 diabetes in the Etude Epidémiologique auprès des Femmes de la Mutuelle Générale de l’Education Nationale-European Prospective Investigation into Cancer and Nutrition cohort. Am J Clin Nutr. 2013;97(3):517–23. Epub 1 Feb 2013.CrossRefPubMed
50.
van Ommen B, Fairweather-Tait S, Freidig A, Kardinaal A, Scalbert A, Wopereis S. A network biology model of micronutrient related health. Br J Nutr. 2008;99 Suppl 3:S72–80. Epub 7 May 2008.PubMed
51.
Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014;72(12):741–62. Epub 20 Nov 2014.CrossRefPubMed
52.
Fardet A, Boirie Y. Associations between diet-related diseases and impaired physiological mechanisms: a holistic approach based on meta-analyses to identify targets for preventive nutrition. Nutr Rev. 2013;71(10):643–56. Epub 15 Oct 2013.CrossRefPubMed
53.
Morio B, Comte B, Martin J-F, Chanseaume E, Alligier M, Junot C, et al. Metabolomics reveals differential metabolic adjustments of normal and overweight subjects during overfeeding. Metabolomics. 2015;11:920. doi:10.​1007/​s11306-014-0750-y.CrossRef
54.
55.
56.
57.
58.
Metadata
Title
Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?
Authors
Martine Laville
Berenice Segrestin
Maud Alligier
Cristina Ruano-Rodríguez
Lluis Serra-Majem
Michael Hiesmayr
Annemie Schols
Carlo La Vecchia
Yves Boirie
Ana Rath
Edmund A. M. Neugebauer
Silvio Garattini
Vittorio Bertele
Christine Kubiak
Jacques Demotes-Mainard
Janus C. Jakobsen
Snezana Djurisic
Christian Gluud
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2160-8

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

Study protocol

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial

Update

Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial

Study protocol

Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial

Methodology

Sample size determination for a binary response in a superiority clinical trial using a hybrid classical and Bayesian procedure

Research

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains