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Volumn 68, Issue 8, 2010, Pages 485-499

Optimizing clinical trial design for assessing the efficacy of functional foods

Author keywords

Chronic diseases; Clinical trial; Functional foods

Indexed keywords

BIOLOGICAL MARKER;

EID: 77956628952     PISSN: 00296643     EISSN: 17534887     Source Type: Journal    
DOI: 10.1111/j.1753-4887.2010.00308.x     Document Type: Review
Times cited : (40)

References (79)
  • 2
    • 77956646995 scopus 로고    scopus 로고
    • Analytic nutrition epidemiology
    • Monsen ER, ed., 2nd edn. Chicago: American Dietetic Association;
    • Yamamoto ME. Analytic nutrition epidemiology. In: Monsen ER, ed. Research: Successful Approaches, 2nd edn. Chicago: American Dietetic Association; 2003:71-86.
    • (2003) Research: Successful Approaches , pp. 71-86
    • Yamamoto, M.E.1
  • 3
    • 0004151208 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration., Available at, Accessed 7 March 2010
    • U.S. Food and Drug Administration. Claims That Can Be Made for Conventional Foods and Dietary Supplements. 2003; Available at: Http://www.fda.gov/Food/Labeling Nutrition/LabelClaims/ucm111447.htm. Accessed 7 March 2010.
    • (2003) Claims That Can Be Made for Conventional Foods and Dietary Supplements
  • 4
    • 3643068245 scopus 로고
    • Experimental studies
    • Margetts BM, Nelson M, eds., New York: Oxford University Press;
    • Margetts BM, Rouse IL. Experimental studies. In: Margetts BM, Nelson M, eds. Design Concepts in Nutritional Epidemiology. New York: Oxford University Press; 1991:385-408.
    • (1991) Design Concepts in Nutritional Epidemiology , pp. 385-408
    • Margetts, B.M.1    Rouse, I.L.2
  • 5
    • 77956623480 scopus 로고    scopus 로고
    • Designing, managing and conducting a clincal nutrition study
    • Monsen ER, Van Horn L, eds., Chicago: American Dietetic Association
    • Griel AE, Psota TL, Kris-Etheron PM. Designing, managing and conducting a clincal nutrition study. In: Monsen ER, Van Horn L, eds. Research: Successful Approaches. Chicago: American Dietetic Association; 2008:101-116.
    • (2008) Research: Successful Approaches , pp. 101-116
    • Griel, A.E.1    Psota, T.L.2    Kris-Etheron, P.M.3
  • 6
    • 77956630453 scopus 로고    scopus 로고
    • Statistical aspects of controlled diet studies
    • Dennis BH, ErshowAG, Obarzanek E, Clevidence BA, eds., 3rd edn. Chicago: American Dietetic Association;
    • Derr JA. Statistical aspects of controlled diet studies. In: Dennis BH, ErshowAG, Obarzanek E, Clevidence BA, eds.Well- Controlled Diet Studies in Humans, A Practical Guide to Design and Management, 3rd edn. Chicago: American Dietetic Association; 1999:10-18.
    • (1999) Well- Controlled Diet Studies in Humans, A Practical Guide to Design and Management , pp. 10-18
    • Derr, J.A.1
  • 7
    • 7144263744 scopus 로고    scopus 로고
    • Understanding controlled trials: Crossover trials
    • Sibbald B, Roberts C. Understanding controlled trials: Crossover trials. BMJ. 1998;316:1719-1720.
    • (1998) BMJ. , vol.316 , pp. 1719-1720
    • Sibbald, B.1    Roberts, C.2
  • 8
    • 11344260005 scopus 로고    scopus 로고
    • Efficiency of the crossover design: An empirical estimation
    • Garcia R, Benet M, Arnau C, Cobo E. Efficiency of the crossover design: An empirical estimation. Stat Med. 2004;23: 3773-3780.
    • (2004) Stat Med. , vol.23 , pp. 3773-3780
    • Garcia, R.1    Benet, M.2    Arnau, C.3    Cobo, E.4
  • 9
    • 0029032735 scopus 로고
    • Quality criteria in human experimental nutrition research
    • Sandstrom B. Quality criteria in human experimental nutrition research. Eur J Clin Nutr. 1995;49:315-322.
    • (1995) Eur J Clin Nutr. , vol.49 , pp. 315-322
    • Sandstrom, B.1
  • 11
    • 77956621233 scopus 로고    scopus 로고
    • Outcomes research and economic analysis
    • Monsen ER, ed., 2nd edn. Chicago: American Dietetic Association;
    • Splett PL. Outcomes research and economic analysis. In: Monsen ER, ed. Research: Successful Approaches, 2nd edn. Chicago: American Dietetic Association; 2003:291-312.
    • (2003) Research: Successful Approaches , pp. 291-312
    • Splett, P.L.1
  • 12
    • 0002912366 scopus 로고    scopus 로고
    • Choosing the study subjects: Specification, sampling and recruitment
    • Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds., 3rd edn. Philadelphia: Lippincott Williams and Wilkins;
    • Hulley SB, Newman TB, Cummings SR. Choosing the study subjects: Specification, sampling and recruitment. In: Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds. Designing Clinical Research: An Epidemiologic Approach, 3rd edn. Philadelphia: Lippincott Williams and Wilkins; 2007:27-36.
    • (2007) Designing Clinical Research: An Epidemiologic Approach , pp. 27-36
    • Hulley, S.B.1    Newman, T.B.2    Cummings, S.R.3
  • 13
    • 77956627761 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Available at:, Accessed 28 November 2009
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. 2009; Available at: Http://www.fda.gov/Food/GuidanceCompliance RegulatoryInformation/GuidanceDocuments/FoodLabeling Nutrition/ucm073332.htm. Accessed 28 November 2009.
    • (2009) Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
  • 15
    • 47349118803 scopus 로고    scopus 로고
    • Conjugated linoleic acids: Why the discrepancy between animal and human studies?
    • Plourde M, Jew S, Cunnane SC, Jones PJH. Conjugated linoleic acids: Why the discrepancy between animal and human studies? Nutr Rev. 2008;66:415-421.
    • (2008) Nutr Rev. , vol.66 , pp. 415-421
    • Plourde, M.1    Jew, S.2    Cunnane, S.C.3    Jones, P.J.H.4
  • 16
    • 0031749963 scopus 로고    scopus 로고
    • Short-term administration of tall oil phytosterols improves plasma lipid profiles in subjects with different cholesterol levels
    • Jones PJH, Howell T, MacDougall DE, Feng JY, Parsons W. Short-term administration of tall oil phytosterols improves plasma lipid profiles in subjects with different cholesterol levels. Metab-Clin Exp. 1998;47:751-756.
    • (1998) Metab-Clin Exp. , vol.47 , pp. 751-756
    • Jones, P.J.H.1    Howell, T.2    MacDougall, D.E.3    Feng, J.Y.4    Parsons, W.5
  • 17
    • 0028822216 scopus 로고
    • Reduction of serum-cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population
    • Miettinen TA, Puska P, Gylling H, Vanhanen H, Vartiainen E. Reduction of serum-cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. N Engl J Med. 1995;333:1308-1312.
    • (1995) N Engl J Med. , vol.333 , pp. 1308-1312
    • Miettinen, T.A.1    Puska, P.2    Gylling, H.3    Vanhanen, H.4    Vartiainen, E.5
  • 18
    • 2942564338 scopus 로고    scopus 로고
    • Plant sterols: Factors affecting their efficacy and safety as functional food ingredients
    • Berger A, Jones PJ, AbuMweis SS. Plant sterols: Factors affecting their efficacy and safety as functional food ingredients. Lipids Health Dis. 2004;3:5.
    • (2004) Lipids Health Dis. , vol.3 , pp. 5
    • Berger, A.1    Jones, P.J.2    AbuMweis, S.S.3
  • 19
    • 41549128934 scopus 로고    scopus 로고
    • Designing a randomized blinded trial
    • Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds. , 3rd edn. Philadelphia, Lippincott Williams and Wilkins;
    • Cummings SR, Grady D, Hulley SB. Designing a randomized blinded trial. In: Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds. Designing Clinical Research: An Epidemiologic Approach, 3rd edn. Philadelphia: Lippincott Williams and Wilkins; 2007:147-162.
    • (2007) Designing Clinical Research: An Epidemiologic Approach , pp. 147-162
    • Cummings, S.R.1    Grady, D.2    Hulley, S.B.3
  • 20
    • 0034020057 scopus 로고    scopus 로고
    • Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner
    • Hallikainen MA, Sarkkinen ES, Uusitupa MIJ. Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner. J Nutr. 2000;130:767-776.
    • (2000) J Nutr. , vol.130 , pp. 767-776
    • Hallikainen, M.A.1    Sarkkinen, E.S.2    Uusitupa, M.I.J.3
  • 21
    • 0032961863 scopus 로고    scopus 로고
    • Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects
    • Hendriks HFJ, Weststrate JA, van Vliet T, Meijer GW. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr. 1999;53:319-327.
    • (1999) Eur J Clin Nutr. , vol.53 , pp. 319-327
    • Hendriks, H.F.J.1    Weststrate, J.A.2    Van Vliet, T.3    Meijer, G.W.4
  • 22
    • 0042206849 scopus 로고    scopus 로고
    • Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels
    • Katan MB, Grundy SM, Jones P, LawM,Miettinen T, Paoletti R. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clin Proc 2003;78:965-978.
    • (2003) Mayo Clin Proc , vol.78 , pp. 965-978
    • Katan, M.B.1    Grundy, S.M.2    Jones, P.3    Law, M.4    Miettinen, T.5    Paoletti, R.6
  • 23
    • 37349060251 scopus 로고    scopus 로고
    • Dietary plant sterols supplementation does not alter lipoprotein kinetics in men with the metabolic syndrome
    • Ooi EM, Watts GF, Barrett PH, et al. Dietary plant sterols supplementation does not alter lipoprotein kinetics in men with the metabolic syndrome. Asia Pac J Clin Nutr. 2007;16: 624-631.
    • (2007) Asia Pac J Clin Nutr. , vol.16 , pp. 624-631
    • Ooi, E.M.1    Watts, G.F.2    Barrett, P.H.3
  • 24
    • 22544452384 scopus 로고    scopus 로고
    • Clinical aspects of human circadian rhythms
    • Klerman EB. Clinical aspects of human circadian rhythms. J Biol Rhythms. 2005;20:375-386.
    • (2005) J Biol Rhythms. , vol.20 , pp. 375-386
    • Klerman, E.B.1
  • 25
    • 33644793780 scopus 로고    scopus 로고
    • The circadian clock within the heart: Potential influence on myocardial gene expression, metabolism, and function
    • Young ME. The circadian clock within the heart: Potential influence on myocardial gene expression, metabolism, and function. Am J Physiol Heart Circ Physiol. 2006;290:H1- 16.
    • (2006) Am J Physiol Heart Circ Physiol. , vol.290
    • Young, M.E.1
  • 26
    • 67549111041 scopus 로고    scopus 로고
    • Plant sterol consumption frequency affects plasma lipid levels and cholesterol kinetics in humans
    • AbuMweis SS, Vanstone CA, Lichtenstein AH, Jones PJH. Plant sterol consumption frequency affects plasma lipid levels and cholesterol kinetics in humans. Eur J Clin Nutr. 2008;63:747-755.
    • (2008) Eur J Clin Nutr. , vol.63 , pp. 747-755
    • AbuMweis, S.S.1    Vanstone, C.A.2    Lichtenstein, A.H.3    Jones, P.J.H.4
  • 28
    • 0141794235 scopus 로고    scopus 로고
    • Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels
    • Jones PJH, Vanstone CA, Raeini-Sarjaz M, St-Onge MP. Phytosterols in low- and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels. J Lipid Res. 2003;44: 1713-1719.
    • (2003) J Lipid Res. , vol.44 , pp. 1713-1719
    • Jones, P.J.H.1    Vanstone, C.A.2    Raeini-Sarjaz, M.3    St-Onge, M.P.4
  • 29
    • 2942514117 scopus 로고    scopus 로고
    • Plant sterol-fortified orange juice effectively lowers cholesterol levels in mildly hypercholesterolemic healthy individuals
    • Devaraj S, Jialal I, Vega-Lopez S. Plant sterol-fortified orange juice effectively lowers cholesterol levels in mildly hypercholesterolemic healthy individuals. Arterioscler Thromb Vasc Biol. 2004;24:E25-E28.
    • (2004) Arterioscler Thromb Vasc Biol. , vol.24
    • Devaraj, S.1    Jialal, I.2    Vega-Lopez, S.3
  • 30
    • 33744540664 scopus 로고    scopus 로고
    • The activity and absorption relationship of cholesterol and phytosterols
    • Romer S, Garti N. The activity and absorption relationship of cholesterol and phytosterols. Colloid Surf A-Physicochem Eng Asp. 2006;282:435-456.
    • (2006) Colloid Surf A-Physicochem Eng Asp. , vol.282 , pp. 435-456
    • Romer, S.1    Garti, N.2
  • 31
    • 3042559581 scopus 로고    scopus 로고
    • Vitamin C in human health and disease is still a mystery? An overview
    • Naidu KA. Vitamin C in human health and disease is still a mystery? An overview. Nutr J. 2003;2:7.
    • (2003) Nutr J. , vol.2 , pp. 7
    • Naidu, K.A.1
  • 32
    • 4143104664 scopus 로고    scopus 로고
    • Stability and shelf life of bioactive compounds during food processing and storage: Soy isoflavones
    • Shimoni E. Stability and shelf life of bioactive compounds during food processing and storage: Soy isoflavones. J Food Sci. 2004;69:R160-R166.
    • (2004) J Food Sci. , vol.69
    • Shimoni, E.1
  • 33
    • 0030898403 scopus 로고    scopus 로고
    • Design criteria for studies examining individual fatty acid effects on cardiovascular disease risk factors: Human and animal studies
    • Kris-Etherton PM, Dietschy J. Design criteria for studies examining individual fatty acid effects on cardiovascular disease risk factors: Human and animal studies. Am J Clin Nutr. 1997;65(Suppl):S1590-S1596.
    • (1997) Am J Clin Nutr. , vol.65 , Issue.SUPPL.
    • Kris-Etherton, P.M.1    Dietschy, J.2
  • 34
    • 77956629771 scopus 로고    scopus 로고
    • Clinical nutrition studies: Maximizing opportunities and managing the challenges
    • Berdanier CD, Dwyer J, Feldman EF, eds., 2nd edn. Boca Raton, FL: CRC Press;
    • Kay CD, Kris-Etheron PM, Psota TL, Maddox Bagshaw D, West SG. Clinical nutrition studies: Maximizing opportunities and managing the challenges. In: Berdanier CD, Dwyer J, Feldman EF, eds. Handbook of Nutrition and Food, 2nd edn. Boca Raton, FL: CRC Press; 2008:693-714.
    • (2008) Handbook of Nutrition and Food , pp. 693-714
    • Kay, C.D.1    Kris-Etheron, P.M.2    Psota, T.L.3    Maddox Bagshaw, D.4    West, S.G.5
  • 35
    • 57049084570 scopus 로고    scopus 로고
    • Omega-3s in food emulsions: Overview and case studies
    • Jacobsen C. Omega-3s in food emulsions: Overview and case studies. AgroFOOD industry hi-tech. 2008;19:9-12.
    • (2008) AgroFOOD industry hi-tech. , vol.19 , pp. 9-12
    • Jacobsen, C.1
  • 36
    • 45949099189 scopus 로고    scopus 로고
    • Advance in dietary enrichment with n-3 fatty acids
    • Moghadasian MH. Advance in dietary enrichment with n-3 fatty acids. Crit Rev Food Sci Nutr. 2008;48:402-410.
    • (2008) Crit Rev Food Sci Nutr. , vol.48 , pp. 402-410
    • Moghadasian, M.H.1
  • 37
    • 33846997847 scopus 로고    scopus 로고
    • Stability and consumer acceptance of long-chain omega-3 fatty acids (eicosapentaenoic acid, 20:5, n-3 and docosahexaenoic acid, 22:6, n-3) in cream-filled sandwich cookies
    • Borneo R, Kocer D, Ghai G, Tepper BJ, KarweMV. Stability and consumer acceptance of long-chain omega-3 fatty acids (eicosapentaenoic acid, 20:5, n-3 and docosahexaenoic acid, 22:6, n-3) in cream-filled sandwich cookies. J Food Sci. 2007;72(Suppl):S049-S054.
    • (2007) J Food Sci. , vol.72 , Issue.SUPPL.
    • Borneo, R.1    Kocer, D.2    Ghai, G.3    Tepper, B.J.4    Karwe, M.V.5
  • 38
    • 34548531550 scopus 로고    scopus 로고
    • Oxidative stability of fish oil enriched drinking yoghurt
    • Nielsen NS, Debnath D, Jacobsen C. Oxidative stability of fish oil enriched drinking yoghurt. Int Dairy J. 2007;17:1478-1485.
    • (2007) Int Dairy J. , vol.17 , pp. 1478-1485
    • Nielsen, N.S.1    Debnath, D.2    Jacobsen, C.3
  • 39
    • 67651176041 scopus 로고    scopus 로고
    • Fortification of reduced-fat cheddar cheese with n-3 fatty acids: Effect on off-flavor generation
    • Martini S, Thurgood JE, Brothersen C, Ward R, McMahon DJ. Fortification of reduced-fat cheddar cheese with n-3 fatty acids: Effect on off-flavor generation. J Dairy Sci. 2009;92: 1876-1884.
    • (2009) J Dairy Sci. , vol.92 , pp. 1876-1884
    • Martini, S.1    Thurgood, J.E.2    Brothersen, C.3    Ward, R.4    McMahon, D.J.5
  • 40
    • 0033667684 scopus 로고    scopus 로고
    • Bitter taste, phytonutrients, and the consumer: A review
    • Drewnowski A, Gomez-Carneros C. Bitter taste, phytonutrients, and the consumer: A review. Am J Clin Nutr. 2000;72: 1424-1435.
    • (2000) Am J Clin Nutr. , vol.72 , pp. 1424-1435
    • Drewnowski, A.1    Gomez-Carneros, C.2
  • 41
    • 0028799659 scopus 로고
    • Incorporating soy proteins into baked products for use in clinical studies
    • Klein BP, Perry AK, Adair N. Incorporating soy proteins into baked products for use in clinical studies. J Nutr. 1995;125(Suppl):S666-S674.
    • (1995) J Nutr. , vol.125 , Issue.SUPPL.
    • Klein, B.P.1    Perry, A.K.2    Adair, N.3
  • 42
    • 33646351792 scopus 로고    scopus 로고
    • Bitterness of soy extracts containing isoflavones and saponins
    • Aldin E, Reimeier CA, Murphy P. Bitterness of soy extracts containing isoflavones and saponins. J Food Sci. 2006;71: S211-S215.
    • (2006) J Food Sci. , vol.71
    • Aldin, E.1    Reimeier, C.A.2    Murphy, P.3
  • 43
    • 38349056380 scopus 로고    scopus 로고
    • S.Y.L. Consumer acceptance of an extruded soy-based high-protein breakfast cereal
    • Yeu K, Lee Y, S.Y. L. Consumer acceptance of an extruded soy-based high-protein breakfast cereal. J Food Sci. 2008;73:S20-S25.
    • (2008) J Food Sci. , vol.73
    • Yeu, K.1    Lee, Y.2
  • 44
    • 0024995464 scopus 로고
    • The use of a run-in to enhance compliance
    • Lang JM. The use of a run-in to enhance compliance. Stat Med. 1990;9:87-93.
    • (1990) Stat Med. , vol.9 , pp. 87-93
    • Lang, J.M.1
  • 45
    • 0037152926 scopus 로고    scopus 로고
    • Managing the resource demands of a large sample size in clinical trials: Can you succeed with fewer subjects?
    • Keech AC, Gebski V. Managing the resource demands of a large sample size in clinical trials: Can you succeed with fewer subjects? Med J Aust. 2002;177:445-447.
    • (2002) Med J Aust. , vol.177 , pp. 445-447
    • Keech, A.C.1    Gebski, V.2
  • 46
    • 2642616191 scopus 로고    scopus 로고
    • Run-in periods in randomized trials: Implications for the application of results in clinical practice
    • Pablos-Mendez A, Barr G, Shea S. Run-in periods in randomized trials: Implications for the application of results in clinical practice. JAMA. 1998;279:222-225.
    • (1998) JAMA. , vol.279 , pp. 222-225
    • Pablos-Mendez, A.1    Barr, G.2    Shea, S.3
  • 47
    • 1642526358 scopus 로고    scopus 로고
    • Principles of recruitment and retention in clinical trials
    • Aitken L, Gallagher R, Madronio C. Principles of recruitment and retention in clinical trials. Int J Nurs Pract. 2003;9:338-346.
    • (2003) Int J Nurs Pract. , vol.9 , pp. 338-346
    • Aitken, L.1    Gallagher, R.2    Madronio, C.3
  • 48
    • 0002901684 scopus 로고    scopus 로고
    • Dietary assessment methodology
    • Coulston AC, Boushey CJ, eds., 2nd edn. Burlington, MA, San Diego, CA, London: Elsevier Inc;
    • Thompson FE, Subar AF. Dietary assessment methodology. In: Coulston AC, Boushey CJ, eds. Nutrition in the Prevention and Treatment of Disease, 2nd edn. Burlington, MA, San Diego, CA, London: Elsevier Inc; 2008:3-39.
    • (2008) Nutrition in the Prevention and Treatment of Disease , pp. 3-39
    • Thompson, F.E.1    Subar, A.F.2
  • 50
    • 77956637906 scopus 로고    scopus 로고
    • Dietary intake assessment: Methods for adults
    • Berdanier CD, Dwyer J, Feldman EB, eds., 2nd edn. Boca Raton, FL: CRC Press;
    • Smiciklas-Wright H, Mitchell DC, Ledikwe JH. Dietary intake assessment: Methods for adults. In: Berdanier CD, Dwyer J, Feldman EB, eds. Handbook of Nutrition and Food, 2nd edn. Boca Raton, FL: CRC Press; 2008:493-507.
    • (2008) Handbook of Nutrition and Food , pp. 493-507
    • Smiciklas-Wright, H.1    Mitchell, D.C.2    Ledikwe, J.H.3
  • 51
    • 0002448764 scopus 로고    scopus 로고
    • Overview of nutritional epidemiology
    • Shils ME, Olson JA, ShikeM, eds., 9th edn. Baltimore: LippincottWilliams and Wilkins;
    • Dwyer J. Overview of nutritional epidemiology. In: Shils ME, Olson JA, ShikeM, eds. Dietary Assessment in Modern Nutrition in Health and Disease, 9th edn. Baltimore: LippincottWilliams and Wilkins; 1999:937-959.
    • (1999) Dietary Assessment in Modern Nutrition in Health and Disease , pp. 937-959
    • Dwyer, J.1
  • 52
    • 6544277004 scopus 로고    scopus 로고
    • Biological sample collection and biological markers of dietary compliance
    • Dennis BH, Ershow AG, Obarzanek E, Clevidence BA, eds., Chicago: American Dietetic Association;
    • Swain JF. Biological sample collection and biological markers of dietary compliance. In: Dennis BH, Ershow AG, Obarzanek E, Clevidence BA, eds. Well-Controlled Diet Studies in Humans, A Practical Guide to Design and Management. Chicago: American Dietetic Association; 1999:379-389.
    • (1999) Well-Controlled Diet Studies in Humans, A Practical Guide to Design and Management , pp. 379-389
    • Swain, J.F.1
  • 53
    • 72149111842 scopus 로고    scopus 로고
    • Biomarkers and their use in nutrition intervention
    • Coulston AC, Boushey CJ, eds., 2nd edn. BurlingtonMA, San Diego CA, London: Elsevier Inc;
    • Lampe JW, Rock CL. Biomarkers and their use in nutrition intervention. In: Coulston AC, Boushey CJ, eds. Nutrition in the Prevention and Treatment of Disease, 2nd edn. BurlingtonMA, San Diego CA, London: Elsevier Inc; 2008:3-39.
    • (2008) Nutrition in the Prevention and Treatment of Disease , pp. 3-39
    • Lampe, J.W.1    Rock, C.L.2
  • 54
    • 0037371913 scopus 로고    scopus 로고
    • Biomarkers of fat and fatty acid intake
    • Arab L. Biomarkers of fat and fatty acid intake. J Nutr. 2003;133(Suppl):S925-S932.
    • (2003) J Nutr. , vol.133 , Issue.SUPPL.
    • Arab, L.1
  • 55
    • 0036927683 scopus 로고    scopus 로고
    • Biomarkers in nutritional epidemiology
    • Bingham SA. Biomarkers in nutritional epidemiology. Public Health Nutr. 2002;5:821-827.
    • (2002) Public Health Nutr. , vol.5 , pp. 821-827
    • Bingham, S.A.1
  • 56
    • 0002624456 scopus 로고    scopus 로고
    • Biochemical indicators of dietary intake
    • Willet W, ed., 2nd edn. New York: Oxford University Press;
    • Hunter D. Biochemical indicators of dietary intake. In: Willet W, ed. Nutritional Epidemiology, 2nd edn. New York: Oxford University Press; 1998:174-243.
    • (1998) Nutritional Epidemiology , pp. 174-243
    • Hunter, D.1
  • 57
    • 37349048147 scopus 로고    scopus 로고
    • Biomarkers of the intake of dietary polyphenols: Strengths, limitations and application in nutrition research
    • Spencer JPE, Abd El Mohsen MM, Minihane AM, Mathers JC. Biomarkers of the intake of dietary polyphenols: Strengths, limitations and application in nutrition research. Br J Nutr. 2008;99:12-22.
    • (2008) Br J Nutr. , vol.99 , pp. 12-22
    • Spencer, J.P.E.1    Abd El Mohsen, M.M.2    Minihane, A.M.3    Mathers, J.C.4
  • 58
    • 0142120730 scopus 로고    scopus 로고
    • Novel risk markers and clinical practice
    • Manolio T. Novel risk markers and clinical practice. N Engl J Med. 2003;349:1587-1589.
    • (2003) N Engl J Med. , vol.349 , pp. 1587-1589
    • Manolio, T.1
  • 59
    • 0034802767 scopus 로고    scopus 로고
    • Considerations in the evaluation of surrogate endpoints in clinical trials: Summary of a National Institutes of Health workshop
    • De Gruttola VG, Clax P, DeMets DL, et al. Considerations in the evaluation of surrogate endpoints in clinical trials: Summary of a National Institutes of Health workshop. Control Clin Trials. 2001;22:485-502.
    • (2001) Control Clin Trials. , vol.22 , pp. 485-502
    • De Gruttola, V.G.1    Clax, P.2    DeMets, D.L.3
  • 60
    • 0024556439 scopus 로고
    • The use of surrogate endpoints in clinical trials (an introduction to a series of four papers)
    • Herson J. The use of surrogate endpoints in clinical trials (an introduction to a series of four papers). Stat Med. 1989;8: 403-404.
    • (1989) Stat Med. , vol.8 , pp. 403-404
    • Herson, J.1
  • 61
    • 0024502084 scopus 로고
    • Surrogate endpoints in clinical trials: Cardiovascular diseases
    • Wittes J, Lakatos E, Probstfield J. Surrogate endpoints in clinical trials: Cardiovascular diseases. Stat Med. 1989;8:415-425.
    • (1989) Stat Med. , vol.8 , pp. 415-425
    • Wittes, J.1    Lakatos, E.2    Probstfield, J.3
  • 62
    • 0035698426 scopus 로고    scopus 로고
    • The use of surrogate endpoints in clinical trials: Focus on clinical trials in cardiovascular diseases
    • Lonn E. The use of surrogate endpoints in clinical trials: Focus on clinical trials in cardiovascular diseases. Pharmacoepidemiol Drug Saf. 2001;10:497-508.
    • (2001) Pharmacoepidemiol Drug Saf. , vol.10 , pp. 497-508
    • Lonn, E.1
  • 63
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definition and operational criteria
    • Prentice RL. Surrogate endpoints in clinical trials: Definition and operational criteria. Stat Med. 1989;8:431-440.
    • (1989) Stat Med. , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 64
    • 2942659668 scopus 로고    scopus 로고
    • Dietary conjugated linoleic acid and body composition
    • Wang Y, Jones PJH. Dietary conjugated linoleic acid and body composition. Am J Clin Nutr. 2004;79(Suppl):S1153-S1158.
    • (2004) Am J Clin Nutr. , vol.79 , Issue.SUPPL.
    • Wang, Y.1    Jones, P.J.H.2
  • 65
    • 48049115014 scopus 로고    scopus 로고
    • The Biomarker-Surrogacy Evaluation Schema: A review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints
    • Lassere MN. The Biomarker-Surrogacy Evaluation Schema: A review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints. Stat Methods Med Res. 2008;17:303-340.
    • (2008) Stat Methods Med Res. , vol.17 , pp. 303-340
    • Lassere, M.N.1
  • 66
    • 42949143199 scopus 로고    scopus 로고
    • Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease
    • Rasnake CM, Trumbo PR, Heinonen TM. Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease. Nutr Rev. 2008;66:76-81.
    • (2008) Nutr Rev. , vol.66 , pp. 76-81
    • Rasnake, C.M.1    Trumbo, P.R.2    Heinonen, T.M.3
  • 67
    • 33847381474 scopus 로고    scopus 로고
    • Biomarkers in the prevention and treatment of atherosclerosis: Need, validation, and future
    • Revkin JH, Shear CL, Pouleur HG, Ryder SW, Orloff DG. Biomarkers in the prevention and treatment of atherosclerosis: Need, validation, and future. Pharmacol Rev. 2007;59:40-53.
    • (2007) Pharmacol Rev. , vol.59 , pp. 40-53
    • Revkin, J.H.1    Shear, C.L.2    Pouleur, H.G.3    Ryder, S.W.4    Orloff, D.G.5
  • 68
    • 0037986306 scopus 로고    scopus 로고
    • End points and United States Food and Drug Administration approval of oncology drugs
    • Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21:1404-1411.
    • (2003) J Clin Oncol. , vol.21 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 69
    • 2542637301 scopus 로고    scopus 로고
    • Biomarkers, surrogate endpoints, and the acceleration of drug development for cancer prevention and treatment: An update prologue
    • Kelloff GJ, Bast RC, Jr, Coffey DS, et al. Biomarkers, surrogate endpoints, and the acceleration of drug development for cancer prevention and treatment: An update prologue. Clin Cancer Res. 2004;10:3881-3884.
    • (2004) Clin Cancer Res. , vol.10 , pp. 3881-3884
    • Kelloff, G.J.1    Bast Jr., R.C.2    Coffey, D.S.3
  • 70
    • 25844468887 scopus 로고    scopus 로고
    • European Medicines Agency, Guideline on the Evaluation of New Medicinal Products in the Treatment of Primary Osteoporosis. Doc. Ref. CPMP/EWP/552/95 Rev., Accessed October 2009
    • European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the Evaluation of New Medicinal Products in the Treatment of Primary Osteoporosis. Doc. Ref. CPMP/EWP/552/95 Rev. 2. 2005; http://www.emea. europa.eu/pdfs/human/ewp/55295enfin.pdf. Accessed October 2009.
    • (2005) Committee for Medicinal Products for Human Use , vol.2
  • 71
    • 77956621505 scopus 로고    scopus 로고
    • Health Canada, Food Directorate, Health Products, Food Branch, Bureau of Nutritional Sciences, March, Available at:, Accessed 28 November 2009
    • Health Canada, Food Directorate, Health Products and Food Branch, Bureau of Nutritional Sciences. Guidance Document for Preparing a Submission for Food Health Claims. March 2009; Available at: Http://www.hc-sc.gc.ca/fn-an/ legislation/ guide-ld/health-claims-guidance-orientation-allegationssante- eng.php. Accessed 28 November 2009.
    • (2009) Guidance Document for Preparing a Submission for Food Health Claims
  • 73
    • 30944440160 scopus 로고    scopus 로고
    • Institutes of Food Technologists Expert Report, Accessed 12 March 2010
    • Institutes of Food Technologists Expert Report. Functional Foods: Opportunities and Challenges. http://www.ift.org/ Knowledge-Center/Read-IFT- Publications/Science-Reports/ Expert-Reports/Functional-Foods.aspx. Accessed 12 March 2010.
    • Functional Foods: Opportunities and Challenges
  • 74
    • 0004226505 scopus 로고    scopus 로고
    • Revised by MJ Campbell University of Southampton: BMJ Publishing Group;, Available at:, Accessed October 2009
    • Swinscow TDV. Statistics at Square One. Revised by MJ Campbell, University of Southampton: BMJ Publishing Group; 1997; Available at: Http://www.bmj.com/statsbk/. Accessed October 2009.
    • (1997) Statistics at Square One
    • Swinscow, T.D.V.1
  • 75
    • 0013230225 scopus 로고    scopus 로고
    • Estimating sample size and power: Applications and examples
    • Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds., 3rd edn. Philadelphia: Lippincott Williams and Wilkins;
    • Browner WS, Newman TB, Hulley SB. Estimating sample size and power: Applications and examples. In: Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB, eds. Designing Clinical Research: An Epidemiologic Approach, 3rd edn. Philadelphia: Lippincott Williams and Wilkins; 2007:65-96.
    • (2007) Designing Clinical Research: An Epidemiologic Approach , pp. 65-96
    • Browner, W.S.1    Newman, T.B.2    Hulley, S.B.3
  • 77
    • 84925570941 scopus 로고    scopus 로고
    • International Conference on Harmanization Harmonised Tripartite Guidelines, Available at:, Accessed 28 November 2009
    • International Conference on Harmanization Harmonised Tripartite Guidelines. Guidelines for Good Clinical Practice. 1996; Available at: Http://www.ich.org/cache/compo/276- 254-1.html. Accessed 28 November 2009.
    • (1996) Guidelines for Good Clinical Practice
  • 78
    • 84925562841 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Available at:, Accessed 28 November 2009
    • U.S. Food and Drug Administration. Clinical Trials Guidance Documents US Food and Drug Administration. 2009; Available at: Http://www.fda.gov/ RegulatoryInformation/ Guidances/ucm122046.htm. Accessed 28 November 2009.
    • (2009) Clinical Trials Guidance Documents US Food and Drug Administration
  • 79
    • 84925560258 scopus 로고    scopus 로고
    • Health Canada., Available at:, Accessed 28 November 2009
    • Health Canada. Guidance Documents for Clinical Trials. 2009; Available at: Http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/applic-demande/guide-ld/clini/ index-eng.php. Accessed 28 November 2009.
    • (2009) Guidance Documents for Clinical Trials


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