Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design

References

• Bian ZX, Shang HC. 2011. Consort 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 154:290–291 (author reply 291–292)
   PubMed Web of Science ®Google Scholar
• Boque N, Campion J, De La Iglesia R, De La Garza AL, Milagro FI, San Roman B, Banuelos O, Martinez JA. 2013. Screening of polyphenolic plant extracts for anti-obesity properties in wistar rats. J Sci Food Agric 93:1226–1232
   PubMed Web of Science ®Google Scholar
• Campbell MK, Piaggio G, Elbourne DR, Altman DG. 2012. Consort 2010 statement: extension to cluster randomised trials. BMJ 345:e5661
   PubMed Web of Science ®Google Scholar
• Chishti HGM, Chishti ND. 1988. The traditional healer's handbook: a classic guide to the medicine of avicenna. Rochester (VT): Inner Traditions
   Google Scholar
• de La Garza AL, Etxeberria U, Lostao MP, San Roman B, Barrenetxe J, Martinez JA, Milagro FI. 2013. Helichrysum and grapefruit extracts inhibit carbohydrate digestion and absorption, improving postprandial glucose levels and hyperinsulinemia in rats. J Agric Food Chem 61:12012–12019
   PubMed Web of Science ®Google Scholar
• de La Garza AL, Milagro FI, Boque N, Campion J, Martinez JA. 2011. Natural inhibitors of pancreatic lipase as new players in obesity treatment. Planta Med 77:773–785
   PubMed Web of Science ®Google Scholar
• Dioscorides P, Goodyer J, Gunther RT. 1934. The greek herbal of dioscorides. Oxford: Oxford University Press
   Google Scholar
• Ebell MH, Siwek J, Weiss BD, Woolf SH, Susman J, Ewigman B, Bowman M. 2004. Strength of recommendation taxonomy (sort): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 69:548–556
   PubMed Web of Science ®Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2011a. General guidance for stakeholders on the evaluation of article 13.1, 13.5 and 14 health claims. EFSA J 9:24
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2011b. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA J 9:13
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2011c. Guidance on the scientific requirements for health claims related to gut and immune function. EFSA J 9:12
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2012a. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA J 10:11
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2012b. Guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. EFSA J 10:13
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2012c. Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions. EFSA J 10:13
   Google Scholar
• EFSA Panel on Dietetic Products, N. a. a. N. 2012d. Guidance on the scientific requirements for health claims related to physical performance. EFSA J 10:9
   Google Scholar
• Etxeberria U, De La Garza AL, Campion J, Martinez JA, Milagro FI. 2012. Antidiabetic effects of natural plant extracts via inhibition of carbohydrate hydrolysis enzymes with emphasis on pancreatic alpha amylase. Expert Opin Ther Targets 16:269–297
   PubMed Web of Science ®Google Scholar
• Fanjul C, Barrenetxe J, De Pablo-Maiso L, Lostao MP. 2015. In vivo regulation of intestinal absorption of amino acids by leptin. J Endocrinol 224:17–23
   PubMed Web of Science ®Google Scholar
• Fernandez-Galilea M, Perez-Matute P, Prieto-Hontoria PL, Martinez JA, Moreno-Aliaga MJ. 2012. Effects of lipoic acid on lipolysis in 3t3-l1 adipocytes. J Lipid Res 53:2296–2306
   PubMed Web of Science ®Google Scholar
• Garcia-Diaz DF, Campion J, Arellano AV, Milagro FI, Moreno-Aliaga MJ, Martinez JA. 2012. Fat intake leads to differential response of rat adipocytes to glucose, insulin and ascorbic acid. Exp Biol Med (Maywood) 237:407–416
   PubMed Web of Science ®Google Scholar
• Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D. 2001. Current methods of the us preventive services task force: a review of the process. Am J Prev Med 20:21–35
   PubMed Web of Science ®Google Scholar
• Ibero-Baraibar I, Abete I, Navas-Carretero S, Massis-Zaid A, Martinez JA, Zulet MA. 2014. Oxidised ldl levels decreases after the consumption of ready-to-eat meals supplemented with cocoa extract within a hypocaloric diet. Nutr Metab Cardiovasc Dis 24:416–422
   PubMed Web of Science ®Google Scholar
• Inigo C, Patel N, Kellett GL, Barber A, Lostao MP. 2007. Luminal leptin inhibits intestinal sugar absorption in vivo. Acta Physiol (Oxf) 190:303–310
   PubMed Web of Science ®Google Scholar
• Katz R. 2004. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 1:189–195
   PubMedGoogle Scholar
• Larrayoz IM, Fernandez-Nistal A, Garces A, Gorraitz E, Lostao MP. 2006. Characterization of the rat na+/nucleoside cotransporter 2 and transport of nucleoside-derived drugs using electrophysiological methods. Am J Physiol Cell Physiol 291:C1395–C1404
   PubMed Web of Science ®Google Scholar
• Martínez JA, Martinez-Gonzalez MA. 2009. Nutrition research methodology. In: Gibney MJ, Lanham-New SA, Cassidy A, Vorster HH, editors. Introduction to human nutrition. 2nd ed. London: Wiley-Blackwell
   Google Scholar
• Martirosyan DM. 2011. Functional foods and chronic diseases: science and practice. CreateSpace Independent Publishing Platform
   Google Scholar
• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. 2012. Reporting of noninferiority and equivalence randomized trials: extension of the consort 2010 statement. JAMA 308:2594–2604
   PubMed Web of Science ®Google Scholar
• Prieto-Hontoria PL, Fernandez-Galilea M, Perez-Matute P, Martinez JA, Moreno-Aliaga MJ. 2013. Lipoic acid inhibits adiponectin production in 3t3-l1 adipocytes. J Physiol Biochem 69:595–600
   PubMed Web of Science ®Google Scholar
• Schulz KF, Altman DG, Moher D. 2010. Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332
   PubMed Web of Science ®Google Scholar
• Toledo Atucha EA, Martínez-González MÁ, Faulín Fajardo FJ, Sánchez Villegas A. 2014. Bioestadística amigable. Barcelona: Elsevier
   Google Scholar
• U.S. Preventive Services Task Force. 2014. Grade definitions. Available at: http://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions. Accessed on October 2014
   Google Scholar
• Valdecantos MP, Perez-Matute P, Gonzalez-Muniesa P, Prieto-Hontoria PL, Moreno-Aliaga MJ, Martinez JA. 2012. Lipoic acid improves mitochondrial function in nonalcoholic steatosis through the stimulation of sirtuin 1 and sirtuin 3. Obesity (Silver Spring) 20:1974–1983
   PubMed Web of Science ®Google Scholar
• Zulet MA, Navas-Carretero S, Lara Y, Sanchez D, Abete I, Flanagan J, Issaly N, et al. 2014. A fraxinus excelsior l. Seeds/fruits extract benefits glucose homeostasis and adiposity related markers in elderly overweight/obese subjects: a longitudinal, randomized, crossover, double-blind, placebo-controlled nutritional intervention study. Phytomedicine 21:1162–1169
   PubMed Web of Science ®Google Scholar