Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
- Conditions
- β-cryptoxanthin Bioavailability From Biofortified Maize in Humans
- Interventions
- Other: Whole grain high-BCX maizeOther: Refined grain high-BCX maizeOther: Whole grain white maize
- Registration Number
- NCT02800408
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Age 20 - 28 y, BMI 19 - 26 kg/m2, non-smoking, not pregnant or trying to become pregnant, and not lactating.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Whole grain high-BCX maize 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. Refined grain high-BCX maize 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. Whole grain white maize 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.
- Primary Outcome Measures
Name Time Method Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t) 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 Outcome Measures
Name Time Method Vitamin A total body stores (µmol vitamin A) by retinol isotope dilution 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.
Vitamin A estimated total liver reserves (µmol vitamin A/g liver) by retinol isotope dilution 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.
Serum zeaxanthin, lutein, and beta-carotene concentration area under the curves ((µmol/L)*t) 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
Serum retinol carbon-13 natural abundance (δ 13C‰) 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.
Trial Locations
- Locations (1)
University of Wisconsin-Madison Nutritional Sciences
🇺🇸Madison, Wisconsin, United States