Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2017-10-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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β-cryptoxanthin Bioavailability From Biofortified Maize in Humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Whole grain high-BCX maize

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.

Group Type EXPERIMENTAL

Whole grain high-BCX maize

Intervention Type 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.

Refined grain high-BCX maize

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.

Group Type EXPERIMENTAL

Refined grain high-BCX maize

Intervention Type 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.

Whole grain white maize

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.

Group Type PLACEBO_COMPARATOR

Whole grain white maize

Intervention Type 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.

Interventions

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Whole grain high-BCX maize

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.

Intervention Type OTHER

Refined grain high-BCX maize

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.

Intervention Type OTHER

Whole grain white maize

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.

Intervention Type OTHER

Other Intervention Names

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Whole grain high-beta-cryptoxanthin maize Whole grain orange maize Refined grain high-beta-cryptoxanthin maize Refined grain orange maize Whole grain low-beta-cryptoxanthin maize

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes