Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

January 22, 2019 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin-Madison Nutritional Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Whole grain low-beta-cryptoxanthin maize

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 days and will be measured on days 0, 12, and 19
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.
14 days and will include the final blood of phase three and another sample 14 days later
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.
14 days and will include the final blood of phase three and another sample 14 days later
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
19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

PepsiCo, Inc.
CIMMYT

Investigators

  • Principal Investigator: Sherry A Tanumihardjo, Ph.D., University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Actual)

November 14, 2016

Study Completion (Actual)

October 23, 2017

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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