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Trial record 88 of 7709 for:    Area Under Curve

Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

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ClinicalTrials.gov Identifier: NCT02800408
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : January 24, 2019
Sponsor:
Collaborators:
PepsiCo, Inc.
CIMMYT
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
β-cryptoxanthin Bioavailability From Biofortified Maize in Humans Other: Whole grain high-BCX maize Other: Refined grain high-BCX maize Other: Whole grain white maize Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Actual Study Start Date : July 21, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : October 23, 2017

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Names:
  • Whole grain high-beta-cryptoxanthin maize
  • Whole grain orange maize

Experimental: 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.
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.
Other Names:
  • Refined grain high-beta-cryptoxanthin maize
  • Refined grain orange maize

Placebo Comparator: 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.
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.
Other Name: Whole grain low-beta-cryptoxanthin maize




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800408


Locations
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United States, Wisconsin
University of Wisconsin-Madison Nutritional Sciences
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
PepsiCo, Inc.
CIMMYT
Investigators
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Principal Investigator: Sherry A Tanumihardjo, Ph.D. University of Wisconsin, Madison

Publications of Results:
Other Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02800408     History of Changes
Other Study ID Numbers: 2015-1607
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Beta-Cryptoxanthin
Provitamins
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs