NCT02800408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 21, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

June 7, 2016

Last Update Submit

January 22, 2019

Conditions

β-cryptoxanthin Bioavailability From Biofortified Maize in Humans

Outcome Measures

Primary Outcomes (1)

  • Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t)

    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 Outcomes (4)

  • Serum retinol carbon-13 natural abundance (δ 13C‰)

    19 days and will be measured on days 0, 12, and 19

  • 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

  • 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

  • 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

Study Arms (3)

Whole grain high-BCX maize

EXPERIMENTAL

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

Refined grain high-BCX maize

EXPERIMENTAL

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

Whole grain white maize

PLACEBO COMPARATOR

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

Interventions

Whole grain high-BCX maizeOTHER

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.

Also known as: Whole grain high-beta-cryptoxanthin maize, Whole grain orange maize
Whole grain high-BCX maize
Refined grain high-BCX maizeOTHER

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.

Also known as: Refined grain high-beta-cryptoxanthin maize, Refined grain orange maize
Refined grain high-BCX maize
Whole grain white maizeOTHER

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.

Also known as: Whole grain low-beta-cryptoxanthin maize
Whole grain white maize

Eligibility Criteria

Age20 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 - 28 y, BMI 19 - 26 kg/m2, non-smoking, not pregnant or trying to become pregnant, and not lactating.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison Nutritional Sciences

Madison, Wisconsin, 53706, United States

Location

Related Publications (6)

  • Arscott SA, Simon PW, Tanumihardjo SA. Anthocyanins in purple-orange carrots (Daucus carota L.) do not influence the bioavailability of beta-carotene in young women. J Agric Food Chem. 2010 Mar 10;58(5):2877-81. doi: 10.1021/jf9041326.

    PMID: 20131807BACKGROUND

  • Horvitz MA, Simon PW, Tanumihardjo SA. Lycopene and beta-carotene are bioavailable from lycopene 'red' carrots in humans. Eur J Clin Nutr. 2004 May;58(5):803-11. doi: 10.1038/sj.ejcn.1601880.

    PMID: 15116084BACKGROUND

  • Molldrem KL, Li J, Simon PW, Tanumihardjo SA. Lutein and beta-carotene from lutein-containing yellow carrots are bioavailable in humans. Am J Clin Nutr. 2004 Jul;80(1):131-6. doi: 10.1093/ajcn/80.1.131.

    PMID: 15213039BACKGROUND

  • Tanumihardjo SA, Horvitz MA, Dosti MP, Simon PW. Serum alpha- and beta-carotene concentrations qualitatively respond to sustained carrot feeding. Exp Biol Med (Maywood). 2009 Nov;234(11):1280-6. doi: 10.3181/0903-RM-106. Epub 2009 Aug 5.

    PMID: 19657072BACKGROUND

  • Osth M, Ost A, Kjolhede P, Stralfors P. The concentration of beta-carotene in human adipocytes, but not the whole-body adipocyte stores, is reduced in obesity. PLoS One. 2014 Jan 8;9(1):e85610. doi: 10.1371/journal.pone.0085610. eCollection 2014.

    PMID: 24416432BACKGROUND

  • Titcomb TJ, Sheftel J, Sowa M, Gannon BM, Davis CR, Palacios-Rojas N, Tanumihardjo SA. beta-Cryptoxanthin and zeaxanthin are highly bioavailable from whole-grain and refined biofortified orange maize in humans with optimal vitamin A status: a randomized, crossover, placebo-controlled trial. Am J Clin Nutr. 2018 Oct 1;108(4):793-802. doi: 10.1093/ajcn/nqy134.

    PMID: 30321275RESULT

Study Officials

  • Sherry A Tanumihardjo, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 15, 2016

Study Start

July 21, 2016

Primary Completion

November 14, 2016

Study Completion

October 23, 2017

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)