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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PepsiCo, Inc.
CIMMYT

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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