Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

University of Wisconsin (UW)

Status: Completed

Conditions: β-cryptoxanthin Bioavailability From Biofortified Maize in Humans

Treatments: Other: Refined grain high-BCX maize; Other: Whole grain white maize; Other: Whole grain high-BCX maize

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02800408

2015-1607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

Whole grain high-BCX maize

Experimental group

Description:

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.

Treatment:

Other: Whole grain high-BCX maize

Refined grain high-BCX maize

Experimental group

Description:

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.

Treatment:

Other: Refined grain high-BCX maize

Whole grain white maize

Placebo Comparator group

Description:

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.

Treatment:

Other: Whole grain white maize