Clinical trials using functional foods provide unique challenges

Journal of Functional Foods

Volumn 45, Issue , 2018, Pages 233-238

  Brown, Lindsay ^a   Caligiuri, Stephanie P B ^b,c   Brown, Dan ^c,d   Pierce, Grant N ^b,c  

^a UNIVERSITY OF SOUTHERN QUEENSLAND   (Australia)

^b The Inst of Cardiovascular Sciences   (Canada)

^c UNIVERSITY OF MANITOBA   (Canada)

^d AGRICULTURE AND AGRI FOOD CANADA   (Canada)

Author keywords

Clinical trial; Functional food; Health food; Natural health products

Indexed keywords

FUNCTIONAL FOOD; HEALTH FOOD; HUMAN; REVIEW; RUNNING;

EID: 85045659590     PISSN: 17564646     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jff.2018.01.024     Document Type: Review

References (37)

1. Alfano, M., Placebo effects and informed consent. American Journal of Bioethics 15:10 (2015), 3–12.
2. Aliani, M., Ryland, D., Pierce, G.N., Effect of flax addition on the flavor profile of muffins and snack bars. Food Research International 44 (2011), 2489–2496.
3. Aliani, M., Ryland, D., Pierce, G.N., Effect of flax addition on the flavor profile and acceptability of bagels. Journal of Food Science 71 (2012), S62–S79.
4. Ames, N., Blewett, H., Storsley, J., Thandapilly, S.J., Zahradka, P., Taylor, C., A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. British Journal of Nutrition 113:9 (2015), 1373–1383.
5. Ander, B.P., Edel, A.L., McCullough, R., Rodriguez-Leyva, D., Rampersad, P.P., Gilchrist, J.S., Pierce, G.N., Distribution of omega-3 fatty acids in tissues of rabbits fed a flaxseed-supplemented diet. Metabolism 59 (2010), 620–627.
6. Ander, B.P., Weber, A.R., Rampersad, P.P., Gilchrist, J.S., Pierce, G.N., Lukas, A., Dietary flaxseed protects against ventricular fibrillation induced by ischemia-reperfusion in normal and hypercholesterolemic rabbits. Journal of Nutrition 134 (2004), 3250–3256.
7. Austria, J.A., Aliani, M., Malcolmson, L.J., Dibrov, E., Blackwood, D.P., Maddaford, T.G., Pierce, G.N., Daily food choices over one year when patient diets are supplemented with milled flaxseed. Journal of Functional Foods 26 (2016), 772–780.
8. Austria, J.A., Richard, M.N., Chahine, M.N., Edel, A.L., Malcolmson, L.J., Dupasquier, C.M.C., Pierce, G.N., Bioavailability of alpha linolenic acid in subjects after ingestion of three different forms of flaxseed. Journal of the American College of Nutrition 27 (2008), 214–221.
9. Baldwin, A., Zahradka, P., Weighell, W., Guzman, R.P., Taylor, C.G., Feasibility and tolerability of daily pulse consumption in individuals with peripheral artery disease. Canadian Journal of Dietetic Practice and Research 24 (2017), 1–5.
10. Bassett, C.M.C., McCullough, R.S., Edel, A.L., Patenaude, A., LaVallee, R.K., Pierce, G.N., The α-linolenic acid content of flaxseed can prevent the atherogenic effects of dietary trans fat. American Journal of Physiology 301 (2011), H2220–H2226.
11. Brown, L., Poudyal, H., Panchal, S.K., Functional foods as potential therapeutic options for metabolic syndrome. Obesity Reviews 16 (2015), 914–941.
12. Caligiuri, S.P., Aukema, H.M., Ravandi, A., Guzman, R., Dibrov, E., Pierce, G.N., Flaxseed consumption reduces blood pressure in patients with hypertension by altering circulating oxylipins via an α-linolenic acid-induced inhibition of soluble epoxide hydrolase. Hypertension 64 (2014), 53–59.
13. Caligiuri, S.P., Aukema, H.M., Ravandi, A., Pierce, G.N., Elevated levels of pro-inflammatory oxylipins in older subjects are normalized by flaxseed consumption. Experimental Gerontology 59 (2014), 51–57.
14. Caligiuri, S.P.B., Penner, B., Pierce, G.N., The HYPERFlax Trial: Determining the anti-HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: Study protocol for a randomized double-blinded clinical trial. Trials, 15, 2014, 232.
15. Caligiuri, S.P., Rodriguez-Leyva, D., Aukema, H.M., Ravandi, A., Weighell, W., Guzman, R., Pierce, G.N., Dietary flaxseed reduces central aortic blood pressure without cardiac involvement but through changes in plasma oxylipins. Hypertension 68 (2016), 1031–1038.
16. Dupasquier, C.M.C., Dibrov, E., Kneesh, A.L., Cheung, P.K.M., Lee, K.G.Y., Alexander, H.K., Pierce, G.N., Dietary flaxseed inhibits atherosclerosis in the LDL receptor-deficient mouse in part through anti-proliferative and anti-inflammatory actions. American Journal of Physiology 293 (2007), H2394–H2402.
17. Dupasquier, C.M., Weber, A.-M., Ander, B.P., Pampersad, P.P., Steigerwald, S., Wigle, J.T., Lukas, A., Effects of dietary flaxseed on vascular contractile function and atherosclerosis in rabbits during prolonged hypercholesterolemia in rabbits. American Journal of Physiology 291 (2006), H2987–H2996.
18. Edel, A.L., Aliani, M., Pierce, G.N., Stability of bioactives in flaxseed and flaxseed-fortified foods. Food Research International 77 (2015), 140–155.
19. Edel, A.L., Patenaude, A.F., Richard, M.N., Dibrov, E., Austria, J.A., Aukema, H.M., Aliani, M., The effect of flaxseed dose on circulating concentrations of alpha-linolenic acid and secoisolariciresinol diglucoside derived enterolignans in young, healthy adults. European Journal of Nutrition 55 (2016), 651–663.
20. Edel, A.L., Rodriguez-Leyva, D., Maddaford, T.G., Caligiuri, S.P., Austria, J.A., Weighell, W., Pierce, G.N., Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. Journal of Nutrition 145 (2015), 749–757.
21. Kaul, N., Kreml, R., Austria, J.A., Richard, M.N., Edel, A.L., Dibrov, E., Pierce, G.N., A comparative effect of fish oil, flaxseed oil and hempseed oil supplementation on selected parameters of cardiovascular health in healthy volunteers. Journal of the American College of Nutrition 27 (2008), 51–58.
22. Kipnis, V., Midthune, D., Freedman, L., Bingham, S., Day, N.E., Riboli, E., Carroll, R.J., Bias in dietary-report instruments and its implications for nutritional epiedemiology. Public Health and Nutrition 5:6A (2002), 915–923.
23. Kirkpatrick, S.I., Reedy, J., Butler, E.N., Dodd, K.W., Subar, A.F., Thompson, F.E., McKinnon, R.A., Dietary assessment in food environment research: A systematic review. American Journal of Preventative Medicine 46:1 (2014), 94–102.
24. Madmani, M. E., Yusuf Solaiman, A., Tamr Agha, K., Madmani, Y., Shahrour, Y., Essali, A., et al. (2014). Coenzyme Q10 for heart failure. Cochrane Database of Systematic Reviews, issue 6, CD008684.
25. Orubu, S. E., Hobson, N. J., Basit, A. W., & Tuleu, C. (2016). The Milky Way: paediatric milk-based dispersible tablets prepared by direct compression – a proof-of-concept study. Journal of Pharmacy and Pharmacology http://doi.org/10.1111/jphp.12570 [Epub ahead of print].
26. Parveen, A., Parveen, B., Parveen, R., Ahmad, S., Challenges and guidelines for clinical trial of herbal drugs. Journal of Pharmacy and BioAllied Science, 2015, 329–333.
27. Patenaude, A., Rodriguez-Leyva, D., Edel, A.L., Dibrov, E., Dupasquier, C.M.C., Austria, J.A., Pierce, G.N., Bioavailability of alpha linolenic acid from flaxseed diets as a function of the age of the subject. European Journal of Clininical Nutrition 63 (2009), 1123–1129.
28. Pierce, G.N., Editorial: Should we clean up the reputation of “dirty drugs”?. Canadian Journal of Physiology and Pharmacology 90 (2012), 1333–1334.
29. Qaim, M., Globalisation of agrifood systems and sustainable nutrition. Proceedings of the Nutrition Society 15 (2016), 1–10.
30. Rodriguez-Leyva, D., Weighell, W., Edel, A.L., LaVallee, R., Dibrov, E., Pinneker, R., Pierce, G.N., Potent anti-hypertensive action of dietary flaxseed in hypertensive patients. Hypertension 62 (2013), 1081–1089.
31. Rodriguez-Leyva, D., Zahradka, P., Ramjiawan, B., Guzman, R., Aliani, M., Pierce, G.N., The effect of dietary flaxseed on improving symptoms of cardiovascular disease in patients with peripheral arterial disease: The rationale and design of the FlaxPAD randomized controlled trial. Contemporary Clinical Trials 32 (2011), 724–730.
32. Sacks, F.M., Campos, H., Dietary therapy in hypertension. New England Journal of Medicine 362 (2010), 2102–2112.
33. Tovar, J., Nilsson, A., Johansson, M., Bjorck, I., Combining functional features of whole-grain barley and legumes for dietary reduction of cardimetabolic risk: A randomized cross-over intervention in mature women. British Journal of Nutrition 111:4 (2014), 706–714.
34. Tsui, T., Boon, H., Boecker, A., Kachan, N., Krahn, M., Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach. BMC Complementary and Alternative Medicine, 12, 2012, 198.
35. Weeks, L., Verhoef, M., Scott, C., Presenting the alternative: Cancer and complementary and alternative medicine in the Canadian print media. Supportive Care in Cancer 15 (2007), 931–938.
36. Whittaker, A., Dinu, M., Cesari, F., Gori, A.M., Fiorillo, C., Becatti, M., Sofi, F., A khorasan wheat-based replacement diet improves risk profile of patients with type 2 diabetes mellitus (T2DM): A randomized crossover trial. European Journal of Nutrition 56 (2017), 1191–1200.
37. Zahradka, P., Wright, B., Weighell, W., Blewett, H., Baldwin, A., Karmin, O., Taylor, C.G., Daily non-soy legume consumption reverses vascular impairment due to peripheral artery disease. Atherosclerosis 230:2 (2013), 310–314.