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| Name | Class |
|---|---|
| PepsiCo, Inc. | INDUSTRY |
| CIMMYT | UNKNOWN |
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The purpose of this study is to determine how well the body absorbs the carotenoid beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this new type of corn contains higher amounts of BCX, it appears more orange in color than traditional types of corn. Understanding how well the body can absorb the BCX from the corn may help companies develop food products that may have improved nutritional quality.
Randomized, blinded, 3 x 3 crossover intervention. Each treatment will last 12 d, followed by a 7-d wash-out period. After the washout, subjects will go back to their regular diet for two weeks before beginning the next cycle. Subjects will report to the research kitchen in the Nutritional Sciences building for their breakfast. Maize will be incorporated into two muffins. Other food choices will be yogurt and other low-fiber foods. Blood samples will be taken at baseline and days 3, 6, 9, 12, 15, and 19. Natural abundance measurements of 13-carbone to 12-carbon will be taken at baseline, day 12 and day 19. Retinol isotope dilution testing will be done at the end of the study to determine total body stores of vitamin A in the subjects. This will include the day 19 blood sample of intervention phase 3 and a final blood sample 14 days after the isotope dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole grain high-BCX maize | Experimental | Whole grain, high-beta-cryptoxanthin (BCX; orange) maize will be incorporated into two muffins to be fed daily for 12 days. Complementary diet will be low in carotenoids. |
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| Refined grain high-BCX maize | Experimental | Refined (degermed) grain, high-beta-cryptoxanthin (BCX; orange) maize will be incorporated into two muffins to be fed daily for 12 days. Complementary diet will be low in carotenoids. |
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| Whole grain white maize | Placebo Comparator | Whole grain, white maize (low in beta-cryptoxanthin) will be incorporated into two muffins to be fed daily for 12 days. Complementary diet will be low in carotenoids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole grain high-BCX maize | Other | The whole grain orange maize will be milled and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t) | Serum beta-cryptoxanthin concentration area under the curve calculated from samples on days 0, 3, 6, 9, 12, 15, 19 of treatment phase | 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Serum retinol carbon-13 natural abundance (δ 13C‰) | Change in serum retinol carbon-13 natural abundance will be assessed from beginning to after each treatment period. This will be done on baseline, day 12 and day 19 blood samples. | 19 days and will be measured on days 0, 12, and 19 |
| Vitamin A total body stores (µmol vitamin A) by retinol isotope dilution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry A Tanumihardjo, Ph.D. | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison Nutritional Sciences | Madison | Wisconsin | 53706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20131807 | Background | Arscott SA, Simon PW, Tanumihardjo SA. Anthocyanins in purple-orange carrots (Daucus carota L.) do not influence the bioavailability of beta-carotene in young women. J Agric Food Chem. 2010 Mar 10;58(5):2877-81. doi: 10.1021/jf9041326. | |
| 15116084 | Background | Horvitz MA, Simon PW, Tanumihardjo SA. Lycopene and beta-carotene are bioavailable from lycopene 'red' carrots in humans. Eur J Clin Nutr. 2004 May;58(5):803-11. doi: 10.1038/sj.ejcn.1601880. |
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| Refined grain high-BCX maize | Other | The refined grain orange maize will be degermed, milled, and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day. |
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| Whole grain white maize | Other | The whole grain white maize will be milled and prepared into muffins to be consumed daily. Muffins will contain minimal beta-cryptoxanthin, matched for dry maize weight. |
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After a blood draw, a carbon-13 labeled vitamin A oral dose will be given to subjects after all treatments. After 14 days, another blood draw will be taken to determine dilution of the stable isotope dose. This will used the final blood sample of intervention phase 3 and a final blood draw 14 days later. |
| 14 days and will include the final blood of phase three and another sample 14 days later |
| Vitamin A estimated total liver reserves (µmol vitamin A/g liver) by retinol isotope dilution | After a blood draw, a carbon-13 labeled vitamin A oral dose will be given to subjects after all treatments. After 14 days, another blood draw will be taken to determine dilution of the stable isotope dose. This will used the final blood sample of intervention phase 3 and a final blood draw 14 days later. | 14 days and will include the final blood of phase three and another sample 14 days later |
| Serum zeaxanthin, lutein, and beta-carotene concentration area under the curves ((µmol/L)*t) | Serum carotenoid concentration area under the curves calculated from samples on days 0, 3, 6, 9, 12, 15, 19 of treatment phase | 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase |
| 15213039 | Background | Molldrem KL, Li J, Simon PW, Tanumihardjo SA. Lutein and beta-carotene from lutein-containing yellow carrots are bioavailable in humans. Am J Clin Nutr. 2004 Jul;80(1):131-6. doi: 10.1093/ajcn/80.1.131. |
| 19657072 | Background | Tanumihardjo SA, Horvitz MA, Dosti MP, Simon PW. Serum alpha- and beta-carotene concentrations qualitatively respond to sustained carrot feeding. Exp Biol Med (Maywood). 2009 Nov;234(11):1280-6. doi: 10.3181/0903-RM-106. Epub 2009 Aug 5. |
| 24416432 | Background | Osth M, Ost A, Kjolhede P, Stralfors P. The concentration of beta-carotene in human adipocytes, but not the whole-body adipocyte stores, is reduced in obesity. PLoS One. 2014 Jan 8;9(1):e85610. doi: 10.1371/journal.pone.0085610. eCollection 2014. |
| 30321275 | Result | Titcomb TJ, Sheftel J, Sowa M, Gannon BM, Davis CR, Palacios-Rojas N, Tanumihardjo SA. beta-Cryptoxanthin and zeaxanthin are highly bioavailable from whole-grain and refined biofortified orange maize in humans with optimal vitamin A status: a randomized, crossover, placebo-controlled trial. Am J Clin Nutr. 2018 Oct 1;108(4):793-802. doi: 10.1093/ajcn/nqy134. |