Human Clinical Studies

Research Publications

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Annelise A. Madison, Martha A. Belury, Rebecca Andridge, Megan E. Renna, M. Rosie Shrout, William B. Malarkey, Jue Lin, Elissa S. Epel, and Janice K. Kiecolt-Glaser (2021). Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults. Molecular Psychiatry, 26.

Jennifer Ahn-Jarvis, Erin Lombardo, Zobeida Cruz-Monserrate, Niharika Badi, Olivia Crowe, Sabrina Kaul, Hannah Komar, Somashekar Krishna, Gregory B. Lesinski, Thomas A. Mace, Mitchell L. Ramsey, Kristen Roberts, Kyle Stinehart, Madelyn Traczek, Darwin L. Conwell, Yael Vodovotz, and Phil A. Hart (2020). Reduction of inflammation in chronic pancreatitis using a soy bread intervention: A feasibility study. Pancreatology, 20 (5).

Joanna K. Hodges, JiangJiang Zhu, Zhontang Yu, Yael Vodovotz, Guy Brock, Geoffrey Sasaski, Priyankar Dey, and Richard S.Bruno (2019). Intestinal-level anti-inflammatory bioactivities of catechin-rich green tea: Rationale, design, and methods of a double-blind, randomized, placebo-controlled crossover trial in metabolic syndrome and healthy adults. Contemporary Clinical Trials, 17.

Colleen K. Spees, Ashlea C. Braun, Emily B. Hill, Elizabeth M. Grainger, James Portner, Gregory S. Young, Matthew D. Kleinhenz, Chureeporn Chitchumroonchokchai, and Steven K. Clinton (2019). Impact of a Tailored Nutrition and Lifestyle Intervention for Overweight Cancer Survivors on Dietary Patterns, Physical Activity, Quality of Life, and Cardiometabolic Profiles. Journal of Oncology, 2019. 

Elizabeth M Grainger, Nancy E Moran, David M Francis, Steven J Schwartz, Lei Wan, Jennifer Thomas-Ahner, Rachel E Kopec, Ken M Riedl, Gregory S Young, Ronney Abaza, Robert R Bahnson, and Steven K Clinton (2018). Novel Tomato-Soy Juice Induces a Dose-Response Increase in Urinary and Plasma Phytochemical Biomarkers in Men with Prostate Cancer. The Journal of Nutrition, 24.

Thomas J Knobloch, Lana K Uhrig, Dennis K Pearl, Bruce C Casto, Blake M Warner, Steven K Clinton, Christine L Sardo-Molmenti, Jeanette M Ferguson, Brett T Daly, Kenneth Riedl, Steven J Schwartz, Yael Vodovotz, Anthony J Buchta Sr , David E Schuller , Enver Ozer, Amit Agrawal, and Christopher M Weghorst (2016). Suppression of Proinflammatory and Prosurvival Biomarkers in Oral Cancer Patients Consuming a Black Raspberry Phytochemical-Rich Troche. Cancer Prevention Research, 9 (2).

Nancy E Moran, Morgan J Cichon, Kenneth M Riedl, Elizabeth M Grainger, Steven J Schwartz, Janet A Novotny, John W Erdman, Jr., and Steven K Clinton (2015). Compartmental and Noncompartmental Modeling of 13C-Lycopene Absorption, Isomerization, and Distribution Kinetics in Healthy Adults. The American Journal of Clinical Nutrition, 102 (6).

Eunice Mah, Teryn N Sapper, Chureeporn Chitchumroonchokchai, Mark L Failla, Kevin E Schill, Steven K Clinton, Gerd Bobe, Maret G Traber, and Richard S Bruno (2015). Α-Tocopherol Bioavailability is Lower in Adults with Metabolic Syndrome regardless of Dairy Fat Co-Ingestion: A Randomized, Double-Blind, Crossover Trial. The American Journal of Clinical Nutrition, 102 (5).

Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl K, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. 2016. Application of a low polyphenol or low ellagitannin dietary intervention and its impact on ellagitannin metabolism in men. Mol Nutr Food Res. Epub ahead of print.

Aschoff JK, Riedl KM, Cooperstone JL, Högel J, Bosy-Westphal A, Schwartz SJ, Carle R, Schweiggert RM. 2016. Urinary excretion of citrus flavanones and their major catabolites after consumption of fresh oranges and pasteurized orange juice – a randomized cross-over study. Mol Nutr Food Res. Epub ahead of print.

Sapper TN, Mah E, Ahn-Jarvis J, McDonald JD, Chitchumroonchokchai C, Reverri EJ, Vodovotz Y, Bruno RS. 2016. A green tea-containing starch confection increases plasma catechins without protecting against postprandial impairments in vascular function in normoglycemic adults. Food Funct. 7(9):3843–53.

Spees CK, Hill EB, Grainger EM, Buell JL, White SE, Kleinhenz MD, Clinton SK. 2016. Feasibility, preliminary efficacy, and lessons learned from a garden-based lifestyle intervention for cancer survivors. Cancer Control. 23(3):302–10.

Knobloch TJ, Uhrig LK, Pearl DK, Casto BC, Warner BM, Clinton SK, Sardo-Molmenti CL, Ferguson JM, Daly BT, Riedl K, Schwartz SJ, Vodovotz Y, Buchta AJ Sr, Schuller DE, Ozer E, Agrawal A, Weghorst CM. 2015. Suppression of pro-Inflammatory and pro-Survival Biomarkers in Oral Cancer Patients Consuming a Black Raspberry Phytochemical-Rich Troche. Cancer Prev Res (Phila). 9(2):159-71.

Moran NE, Cichon MJ, Riedl KM, Grainger EM, Schwartz SJ, Novotny JA, Erdman JW, Clinton SK. 2015. Compartmental and Noncompartmental Modeling of 13C-Lycopene Absorption, Isomerization, and Distribution Kinetics in Healthy Adults. Am J Clin Nutr, November. 102(6):1436-49.

Ahn-Jarvis J, Clinton SK, Grainger EM, Riedl K, Schwartz SJ, Lee MT, Raul C, Young GS, Lesinski GB, Vodovotz Y. 2015. Isoflavone Pharmacokinetics and Metabolism after Consumption of a Standardized Soy and Soy-Almond Bread in Men with Asymptomatic Prostate Cancer. Cancer Prev Res8(11):1045-54.

Lesinski GB, Reville PK, Mace TA, Young GS, Ahn-Jarvis J, Thomas-Ahner J, Vodovotz Y, Ameen Z, Grainger E, Riedl K, Schwartz SJ, Clinton SK. 2015. Consumption of soy isoflavone enriched bread in men with prostate cancer is associated with reduced pro-inflammatory cytokines and immune suppressive cells. Cancer Prev Res8(11):1036-1044.

Grainger EM, Hadley CW, Moran NE, Riedl KM, Gong MC, Pohar K, Schwartz SJ, and Clinton SK. 2015. A Comparison of Plasma and Prostate Lycopene in Response to Typical Servings of Tomato Soup, Sauce or Juice in Men before Prostatectomy. Br J Nutr, July, 1–12.

Straka S, Lester JL, Cole RM, Andridge RR, Puchala S, Rose AM, Clinton SK, Belury MA, Yee LD. 2015. Incorporation of eicosapentaenioic and docosahexaenoic acids into breast adipose tissue of women at high risk of breast cancer: A randomized clinical trial of dietary fish and n-3 fatty acid capsules. Mol Nutr Food Res. 59(4):763-72.

Mah E, Pei R, Guo Y, Masterjohn C, Ballard KD, Taylor BA, Taylor AW, Traber MG, Volek JS, Bruno RS. 2015. Greater γ-tocopherol status during acute smoking abstinence with nicotine replacement therapy improved vascular endothelial function by decreasing 8-iso-15(S)-prostaglandin F2α. Exp Biol Med (Maywood). 240(4):527-33.

Cooperstone JL, Ralston RA, Riedl KM, Haufe TC, Schweiggert RM, King SA, Schwartz SJ. 2015. Enhanced bioavailability of lycopene when consumed as cis-isomers from tangerine compared to red tomato juice, a randomized, cross-over clinical trial. Mol Nutr Food Res. 59(4):658-69.

Ballard KD, Bruno RS. 2015. Protective role of dairy and its constituents on vascular independent of blood pressure-lowering activities. Nutr Rev. 73(1):36-50.

Biddle MJ, Lennie TA, Bricker G V, Kopec RE, Schwartz SJ, Moser DK. 2014. Lycopene dietary intervention: A pilot study in patients with heart failure. J Cardiovasc Nurs. 30(3):205-12.

Guo Y, Mah E, Bruno RS. 2014. Quercetin bioavailability is associated with inadequate plasma vitamin C status and greater plasma endotoxin in adults. Nutrition. 30(11-12):1279–86.

Kopec RE, Cooperstone JL, Schweiggert RM, Young GS, Harrison EH, Francis DM, Clinton SK, Schwartz SJ. 2014. Avocado consumption enhances human postprandial provitamin A absorption and conversion from a novel high-carotene tomato sauce and from carrots. J Nutr. 144(8):1158-66.

Zu K, Mucci L, Rosner BA, Clinton SK, Loda M, Stampfer MJ, Giovannucci E. 2014. Dietary lycopene, angiogenesis, and prostate cancer: A prospective study in the prostate-specific antigen era. J Natl Cancer Inst. 106(2):djt430.

Schweiggert RM, Kopec RE, Villalobos-Gutierrez MG, Högel J, Quesada S, Esquivel P, Schwartz SJ, Carle R. 2014. Carotenoids are more bioavailable from papaya than from tomato and carrot in humans: a randomised cross-over study. Br J Nutr. 111(3):490-8.

Mangano KM, Hutchins-Wiese HL, Kenny AM, Walsh SJ, Abourizk RH, Bruno RS, Lipcius R, Fall P, Kleppinger A, Kenyon-Pesce L, Prestwood KM, Kerstetter JE. 2013. Soy proteins and isoflavones reduce interleukin-6 but not serum lipids in older women: a randomized controlled trial. Nutr Res. 33(12):1026–33.

Guo Y, Mah E, Davis CG, Jalili T, Ferruzzi MG, Chun OK, Bruno RS. 2013. Dietary fat increases quercetin bioavailability in overweight adults. Mol Nutr Food Res. 57(5):896–905.

Mah E, Pei R, Guo Y, Ballard KD, Barker T, Rogers VE, Parker BA, Taylor AW, Traber MG, Volek JS, Bruno RS. 2013. γ-Tocopherol-rich supplementation additively improves vascular endothelial function during smoking cessation. Free Radic Biol Med. 65C:1291–9.

Bohn T, Blackwood M, Francis D, Tian Q, Schwartz SJ, Clinton SK. 2013. Bioavailability of phytochemical constituents from a novel soy fortified lycopene rich tomato juice developed for targeted cancer prevention trials. Nutr Cancer. 65(6):919-29.

Goltz SR, Sapper TN, Failla ML, Campbell WW, Ferruzzi MG. 2013. Carotenoid bioavailability from raw vegetables and a moderate amount of oil in human subjects is greatest when the majority of daily vegetables are consumed at one meal. Nutr Res. 33(5):358-66.

Ahn-Jarvis J, Schwartz S, Vodovotz Y. 2013. Optimizing isoflavone-rich food delivery systems for human clinical trials. In: Isoflavones: Chemistry, Analysis, Function and Effects. Ed. Preedy VR. RSC Publishing, Cambridge, UK.

Ahn-Jarvis J, Clinton SK, Riedl KM, Vodovotz Y, Schwartz SJ. 2012. Impact of food matrix on isoflavone metabolism and cardiovascular biomarkers in adults with hypercholesterolemia. Food Funct. 3(10):1051-1058.

Goltz SR, Campbell WW, Chitchumroonchokchai C, Failla ML, Ferruzzi MG. 2012. Meal triacylglycerol profile modulates postprandial absorption of carotenoids in humans. Mol Nutr Food Res. 56(6):866-877.

Chen T, Yan F, Qian J, Guo M, Zhang H, Tang X, Chen F, Stoner GD, Wang X. 2012. Randomized phase II trial of lyophilized strawberries in patients with dysplastic precancerous lesions of the esophagus. Cancer Prev Res. (Phila). 5(1):41–50.

Chitchumroonchokchai C, Riedl KM, Suksumrarn S, Clinton SK, Kinghorn AD, Failla ML. 2012. Xanthones in mangosteen juice are absorbed and partially conjugated by healthy adults. J Nutr. 142(4):675-680.

Barona J, Jones JJ, Kopec RE, Comperatore M, Andersen C, Schwartz SJ, Lerman RH, Fernandez ML. 2012. A Mediterranean-style low-glycemic-load diet increases plasma carotenoids and decreases LDL oxidation in women with metabolic syndrome. J Nutr Biochem. 23(6):609-615.

Wang LS, Arnold M, Huang YW, Sardo C, Seguin C, Martin E, Huang TH, Riedl K, Schwartz S, Frankel W, Pearl D, Xu Y, Winston J, 3rd, Yang GY, Stoner G. 2011. Modulation of genetic and epigenetic biomarkers of colorectal cancer in humans by black raspberries: a phase I pilot study. Clin Cancer Res. 17(3):598-610.

Simmons AL, Miller CK, Clinton SK, Vodovotz Y. 2011. A comparison of satiety, glycemic index, and insulinemic index of wheat-derived soft pretzels with or without soy. Food Funct. 2(11):678-683.

McLaughlin JM, Olivo-Marston S, Vitolins MZ, Bittoni M, Reeves KW, Degraffinreid CR, Schwartz SJ, Clinton SK, Paskett ED. 2011. Effects of tomato- and soy-rich diets on the IGF-I hormonal network: A crossover study of postmenopausal women at high risk for breast cancer. Cancer Prev Res. 4(5):702-710.

Cuyun Carter GB, Katz ML, Ferketich AK, Clinton SK, Grainger EM, Paskett ED, Bloomfield CD. 2011. Dietary intake, food processing, and cooking methods among Amish and non-Amish adults living in Ohio Appalachia: relevance to nutritional risk factors for cancer. Nutr Cancer. 63(8):1208-1217.

Clarke JD, Riedl K, Bella D, Schwartz SJ, Stevens JF, Ho E. 2011. Comparison of isothiocyanate metabolite levels and histone deacetylase activity in human subjects consuming broccoli sprouts or broccoli supplement. J Agric Food Chem. 59(20):10955-10963.

Clarke JD, Hsu A, Riedl K, Bella D, Schwartz SJ, Stevens JF, Ho E. 2011. Bioavailability and inter-conversion of sulforaphane and erucin in human subjects consuming broccoli sprouts or broccoli supplement in a cross-over study design. Pharmacol Res. 64(5):456-463.

Asp ML, Collene AL, Norris LE, Cole RM, Stout MB, Tang SY, Hsu JC, Belury MA. 2011. Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: A randomized, double-masked, crossover study. Clin Nutr. 30(4):443-449.

Yee LD, Lester JL, Cole RM, Richardson JR, Hsu JC, Li Y, Lehman A, Belury MA, Clinton SK. 2010. Omega-3 Fatty acid supplements in women at high risk of breast cancer have dose-dependent effects on breast adipose tissue fatty acid composition. Amer J Clin Nutr. 91(5):1185-1194.

McDaniel JC, Ahijevych K, Belury M. 2010. Effect of n-3 oral supplements on the n-6/n-3 ratio in young adults. West J Nurs Res. 32(1):64-80.

Mucci LA, Powolny A, Giovannucci E, Liao ZM, Kenfield SA, Shen RL, Stampfer MJ, Clinton SK. 2009. Prospective study of prostate tumor angiogenesis and cancer-specific mortality in the Health Professionals Follow-Up Study. J Clin Oncol. 27(33):5627-5633.

Norris LE, Collene AL, Asp ML, Hsu JC, Liu L-F, Richardson JR, Li D, Bell D, Osei K, Jackson RD, Belury MA. 2009. Comparison of dietary conjugated linoleic acid with safflower oil on body composition in obese postmenopausal women with type 2 diabetes mellitus. Am. J. Clin. Nutr. 90(3):468-476.

Mallery SR, Zwick JC, Pei P, Tong M, Larsen PE, Shumway BS, Lu B, Fields HW, Mumper RJ, Stoner GD. 2008. Topical application of a bioadhesive black raspberry gel modulates gene expression and reduces cyclooxygenase 2 protein in human premalignant oral lesions. Cancer Res. 68(12):4945-4957.

Grainger EM, Kim HS, Monk JP, Lemeshow SA, Gong M, Bahnson RR, Clinton SK. Consumption of dietary supplements and over-the-counter and prescription medications in men participating in the Prostate Cancer Prevention Trial at an academic center. Urol Oncol 2008 Mar;26(2):125-32.

Grainger EM, Schwartz SJ, Wang S, Unlu NZ, Boileau TW, Ferketich AK, Monk JP, Gong MC, Bahnson RR, DeGroff VL, Clinton SK. A combination of tomato and soy products for men with recurring prostate cancer and rising prostate specific antigen. Nutr Cancer 2008 Mar;60(2):145-54.

Unlu NZ, Bohn T, Francis DM, Nagaraja HN, Clinton SK, Schwartz SJ. Lycopene from heat-induced cis-isomer-rich tomato sauce is more bioavailable than from all-trans-rich tomato sauce in human subjects. Br J Nutr 2007 Jul;98(1):140-6.

Walsh KR, Haak SJ, Bohn T, Tian Q, Schwartz SJ, Failla ML. Isoflavonoid glucosides are deconjugated and absorbed in the small intestine of human subjects with ileostomies. Am J Clin Nutr 2007 Apr;85(4):1050-6.

Unlu NZ, Bohn T, Francis DM, Clinton SK, Schwartz SJ. Carotenoid absorption in humans consuming tomato sauces obtained from tangerine or high-beta-carotene varieties of tomatoes. J Agric Food Chem 2007 Feb;55(4):1597-603.

Tian Q, Giusti MM, Stoner GD, Schwartz SJ. Urinary excretion of black raspberry (Rubus occidentalis) anthocyanins and their metabolites. J Agric Food Chem 2006 Feb;54(4):1467-72.

Miller EC, Boileau TWM, DeGroff VL, Bray T, Unlu NZ, Schwartz SJ, Clinton SK. Combined dietary intervention with tomato-based foods and soy in men with recurrent asymptomatic prostate cancer [Abstract]. In: J Nutr; Dec; Bethesda, MD: Amer Society Nutritional Science; 2005. p. 3046S-7S.

Kresty LA, Frankel WL, Hammond CD, Baird ME, Mele JM, Stoner GD, Fromkes JJ. Transitioning from preclinical to clinical chemopreventive assessments of lyophilized black raspberries: interim results show berries modulate markers of oxidative stress in Barrett’s esophagus patients. Nutr Cancer 2006 Jan;54(1):148-56.

Kresty LA, Stoner GD, Frankel WL, Hammond CD, Baird ME, Mele JM, Fromkes JJ. Interim results of a pilot study evaluating the chemopreventive potential of lyophilized black raspberries in patients with Barretts esophagus [Abstract]. In: Cancer Epidemiol;Biomarkers Prev; Nov; Philadelphia, PA: Amer Assoc Cancer Research; 2005. p. 2734S.

Stoner GD, Sardo C, Apseloff G, Mullet D, Wargo W, Pound V, Singh A, Sanders J, Aziz R, Casto B, Sun X. Pharmacokinetics of anthocyanins and ellagic acid in healthy volunteers fed freeze-dried black raspberries daily for 7 days. J Clin Pharmacol 2005 Oct;45(10):1153-64.

Bohn T, Blackwood M, Schwartz SJ, Clinton SK, Vodovotz Y, Failla ML, Bomser JA, Hooker NH, Francis DM. Improved blood lipid and antioxidant status in healthy subjects consuming soy fortified high lycopene tomato juice [Abstract]. In: FASEB J; Mar; Bethesda, MD: Federation Amer Soc Exp Biol; 2005. p. A998.

Unlu NZ, Bohn T, Clinton SK, Schwartz SJ. Carotenoid absorption from salad and salsa by humans is enhanced by the addition of avocado or avocado oil. J Nutr 2005;135(3):431-6.