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Completed

NCT Number: NCT02800408

Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

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.

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Key information

Conditions

β-cryptoxanthin Bioavailability From Biofortified Maize in Humans

Age range

20 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison Nutritional Sciences

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Whole grain high-beta-cryptoxanthin maize, Whole grain orange maize

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.

Other names: Refined grain high-beta-cryptoxanthin maize, Refined grain orange maize

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.

Other names: Whole grain low-beta-cryptoxanthin maize

Primary outcomes

  1. Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t)

    Time frame: 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

    Serum beta-cryptoxanthin concentration area under the curve calculated from samples on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

Secondary outcomes

  1. Serum retinol carbon-13 natural abundance (δ 13C‰)

    Time frame: 19 days and will be measured on days 0, 12, and 19

    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.

  2. Vitamin A total body stores (µmol vitamin A) by retinol isotope dilution

    Time frame: 14 days and will include the final blood of phase three and another sample 14 days later

    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.

  3. Vitamin A estimated total liver reserves (µmol vitamin A/g liver) by retinol isotope dilution

    Time frame: 14 days and will include the final blood of phase three and another sample 14 days later

    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.

  4. Serum zeaxanthin, lutein, and beta-carotene concentration area under the curves ((µmol/L)*t)

    Time frame: 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

    Serum carotenoid concentration area under the curves calculated from samples on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • CIMMYT
  • PepsiCo, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 15, 2016
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.