Clinical trial NCT02800408: Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Official title: Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: β-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: PepsiCo, Inc.
name: CIMMYT
First posted: 2016-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 20 - 28 y, BMI 19 - 26 kg/m2, non-smoking, not pregnant or trying to become pregnant, and not lactating.

Exclusion Criteria:

* Smoker
* BMI \< 19 kg/m\^2 or BMI \> 26 kg/m\^2
* Women: pregnant or trying to become pregnant, breast-feeding
* Weight loss greater than or equal to 10 pounds (4.5 kilograms) during the 3 months prior to recruitment
* Actively trying to lose weight
* Fat malabsorptive disorders
* Inability to refrain from drinking alcohol when requested
* Amenorrhea
* Acute or chronic illness, including hepatitis
* Current or previous history of anorexia or bulimia
* History of iron deficiency anemia
* Inability to pick up food from research facility and eat meals on site when requested
* Planned vacation of \>1 week duration during the study
* Known scheduling conflict with the blood draws
* Major food allergies/intolerance to ingredients used in the meals
* Unwillingness to discontinue personal nutritional supplements/vitamins when asked to
* Concurrent participation in other studies
* Social circumstances that would make it difficult to consume a study food
* Family member already enrolled in the study

Primary outcomes:
measure: Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t)
timeFrame: 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase
Secondary outcomes:
measure: Serum retinol carbon-13 natural abundance (δ 13C‰)
timeFrame: 19 days and will be measured on days 0, 12, and 19
measure: Vitamin A total body stores (µmol vitamin A) by retinol isotope dilution
timeFrame: 14 days and will include the final blood of phase three and another sample 14 days later
measure: Vitamin A estimated total liver reserves (µmol vitamin A/g liver) by retinol isotope dilution
timeFrame: 14 days and will include the final blood of phase three and another sample 14 days later
measure: Serum zeaxanthin, lutein, and beta-carotene concentration area under the curves ((µmol/L)*t)
timeFrame: 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Nutritional Sciences
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sherry A Tanumihardjo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.