- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153968
Bioefficacy of Beta-cryptoxanthin From Biofortified Maize (BIOCRYPT)
Determination of Relative Bioavailability, Bioconversion and Bioefficacy of β-cryptoxanthin in Comparison to β-carotene From Biofortified Maize and External Stable Isotopes Using Compartmental Modelling
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite advances in reducing vitamin A (VA) deficiency worldwide, the prevalence remains highest and unchanged in sub-Saharan Africa and South Asia. Efficacy studies have demonstrated that increasing provitamin A carotenoid (pVAC) intake through consuming pVAC biofortified crops results in increased circulating β-carotene (βC) and VA body stores. It has also been shown that consumption of biofortified maize improved VA total body stores (TBS) as effectively as preformed VA supplementation, and significantly improved visual function in marginally VA deficient children. Despite the fact that βC is the primary focus of breeding programs for pVAC biofortified maize, there is convincing evidence that comparable dietary intakes of βC and β-cryptoxanthin (βCX) would result in 7-fold greater concentrations of βCX in blood.
The study is designed to determine for the first time the bioefficacy of βCX in comparison to βC in humans using state of the art isotope dilution techniques in combination with compartmental modelling. The project is conducted in two phases: Phase 1) the determination of best time points for assessment of βCX bioconversion, intestinal and postintestinal bioefficacy as well as quantifying TBS of VA in healthy volunteers; Phase 2) to test the bioefficacy of βCX and βC in maize by comparing a high βCX and low βC maize variety to a high βC and low βCX maize variety.
Phase 1 of the study involves 1 long study day (D0), where 10 ml of blood will be taken every 2 hours, via cannulation, for a total of 12 hours (70 ml of blood total). Subsequently, there are 13 followup visits on the mornings of Days 1, 2, 4, 7, 11, 14, 21, 28, 35, 49, 63, 77, and 91 where one 10 ml blood sample is taken.
Phase 2 of the study involves 2 whole days (D0 and D21) where approximately 10 ml of blood will be taken every 30-60 minutes, via cannulation, for a total of 8 hours (110 ml of blood total). Subsequently, there are 3 follow-up visits on the mornings of Days 1, 7, and 22 where one 10 ml blood sample is taken on each occasion.
In the mornings of the long/whole study days at either D0 or D21, participants will receive the muffin test meal before stable isotopes, dissolved in sunflower oil, are administered via oral pipette. At D0 or D21, the total dose of pVACs (labelled and unlabelled carotenoids) consumed in the muffin and oil is 3 mg alongside 0.4 mg of pre-formed VA.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anthony Oxley, PhD
- Phone Number: 0191 208 1403
- Email: anthony.oxley@ncl.ac.uk
Study Contact Backup
- Name: Georg Lietz, PhD
- Phone Number: 0191 208 6893
- Email: georg.lietz@ncl.ac.uk
Study Locations
-
-
Tyne & Wear
-
Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE2 4HH
- Recruiting
- Newcastle University
-
Contact:
- Anthony Oxley, PhD
- Phone Number: 0191 208 1403
- Email: anthony.oxley@ncl.ac.uk
-
Principal Investigator:
- Georg Lietz, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Females who are pregnant or lactating.
- Not disclosing use and type of contraceptives.
- Acute or chronic illness.
- Concurrent participation in another study.
- Unwillingness to discontinue personal nutritional supplements/vitamins.
- Major food allergies/intolerance to study ingredients.
- Previous history of anorexia or bulimia.
- Inability to refrain from drinking alcohol when requested.
- Fat mal-absorptive disorders or iron deficiency anaemia.
- Dietary preformed vitamin A intake >600 µg/d.
- BMI <20 and >29 kg/m2.
- Smoking.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1
Determination absorption and bioconversion kinetics of [13C14]β-cryptoxanthin and provide external validation for single-sample prediction methods.
|
Phase 1: 2.0mg of [13C14]β-cryptoxanthin, 1.0mg of [13C10]β-carotene and 0.4mg [2H6]retinyl acetate are given in sunflower oil at Time 0. Phase 2: 1.5mg of [13C14]β-cryptoxanthin, 0.75mg of [13C10]β-carotene, 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.25mg β-carotene and 0.5mg β-cryptoxanthin from maize are given at Time 0. Then, 0.75mg of [13C14]β-cryptoxanthin, 1.5mg of [13C10]β-carotene, and 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.5mg β-carotene and 0.25mg β-cryptoxanthin from maize are given on day 21.
Other Names:
|
Experimental: Phase 2
Test the bioefficacy of provitamin A carotenoids (pVACs) in maize by comparing a high β-cryptoxanthin:β-carotene (βCX:βC) variety to a low βCX:βC variety in combination with external [13C]-labelled pVACs.
|
Phase 1: 2.0mg of [13C14]β-cryptoxanthin, 1.0mg of [13C10]β-carotene and 0.4mg [2H6]retinyl acetate are given in sunflower oil at Time 0. Phase 2: 1.5mg of [13C14]β-cryptoxanthin, 0.75mg of [13C10]β-carotene, 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.25mg β-carotene and 0.5mg β-cryptoxanthin from maize are given at Time 0. Then, 0.75mg of [13C14]β-cryptoxanthin, 1.5mg of [13C10]β-carotene, and 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.5mg β-carotene and 0.25mg β-cryptoxanthin from maize are given on day 21.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioefficacy of β-cryptoxanthin
Time Frame: Phase 1 = 91 days. Phase 2 = 22 days.
|
Plasma concentrations of [13C14]-β-cryptoxanthin, [13C7]-retinyl esters, and [13C7]-retinol.
|
Phase 1 = 91 days. Phase 2 = 22 days.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BH183438
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Vitamin A Deficiency
-
SourseCitruslabsActive, not recruitingMood | Energy Supply; Deficiency | B12 Deficiency VitaminUnited States
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustEnrolling by invitationIron Deficiency (Without Anemia) | B12 Deficiency VitaminUnited Kingdom
-
Kansas State UniversityNational Institute for Medical Research, Tanzania; United States Department... and other collaboratorsCompletedAnemia, Iron-Deficiency | Deficiency, Vitamin A
-
Newcastle UniversityBill and Melinda Gates Foundation; Institute of Nutrition of Central America... and other collaboratorsUnknownVitamin A Deficiency | Vitamin A Toxicity | Hypervitaminosis AGuatemala, United Kingdom
-
Fatih Sultan Mehmet Training and Research HospitalActive, not recruitingVitamin D Deficiency | Lipedema | B12 Deficiency VitaminTurkey
-
Nottingham University Hospitals NHS TrustNorthern Care Alliance NHS Foundation Trust; Barts & The London NHS Trust; University... and other collaboratorsNot yet recruitingParesthesia | Neurologic Symptoms | B12 Deficiency Vitamin | Nitrous Oxide Abuse | Subacute Combined Cord Degeneration
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVitamin A Deficiency | Vitamin A ToxicityUnited States
-
University of California, DavisPenn State University; University of Ghana; Newcastle University; Helen Keller...CompletedAnemia | Dietary Habits | Iron Deficiency | Vitamin A Deficiency | Vitamin B 12 Deficiency | Folate Deficiency | Zinc DeficiencyGhana
Clinical Trials on β-cryptoxanthin
-
Singapore Institute for Clinical SciencesDSM Nutritional Products, Inc.CompletedBeta-cryptoxanthin SupplementationSingapore
-
University of Wisconsin, MadisonPepsiCo, Inc.; CIMMYTCompletedβ-cryptoxanthin Bioavailability From Biofortified Maize in HumansUnited States
-
Cyclo Therapeutics, Inc.Active, not recruitingNiemann-Pick Disease, Type C1United States
-
Puerta de Hierro University HospitalCompletedHypercholesterolemia | OsteoporosisSpain
-
Auburn UniversityUniversity of Missouri-Columbia; University of UtahRecruiting
-
St. Boniface HospitalAgriculture and Agri-Food CanadaActive, not recruiting
-
McMaster UniversityRecruiting
-
Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImagingActive, not recruitingParkinson DiseaseUnited States
-
University of CopenhagenCompleted
-
Beingmate Baby & Child Food Co Ltd .Shanghai Jiao Tong University School of MedicineUnknown