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Bioefficacy of Beta-cryptoxanthin From Biofortified Maize

NCT04153968 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-04

No results posted yet for this study

Summary

Since no quantitative information currently exists on how effectively the pro-vitamin A carotenoid (pVAC) β-cryptoxanthin (βCX) is converted to vitamin A (VA) in humans, this proof of principle study aims to compare the efficacy of both βCX and β-carotene (βC) to yield VA from biofortified maize. This data is critical before the breeding strategy for biofortified maize is directed towards high βCX-containing varieties in order to reduce VA deficiency in low-income countries.

Conditions

  • Vitamin A Deficiency

Interventions

DIETARY_SUPPLEMENT

β-cryptoxanthin

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.

Sponsors & Collaborators

  • International Food Policy Research Institute

    collaborator OTHER

  • Penn State University

    collaborator OTHER

  • Newcastle University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153968 on ClinicalTrials.gov