Bioefficacy of Beta-cryptoxanthin From Biofortified Maize

NCT04153968 | Unknown

• 1 other identifier: BH183438
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bioefficacy of β-cryptoxanthin

  Plasma concentrations of \[13C14\]-β-cryptoxanthin, \[13C7\]-retinyl esters, and \[13C7\]-retinol.

  Phase 1 = 91 days. Phase 2 = 22 days.

Study Arms (2)

Phase 1

EXPERIMENTAL

Determination absorption and bioconversion kinetics of \[13C14\]β-cryptoxanthin and provide external validation for single-sample prediction methods.

Dietary Supplement: β-cryptoxanthin

Phase 2

EXPERIMENTAL

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.

Dietary Supplement: β-cryptoxanthin

Interventions

β-cryptoxanthin DIETARY_SUPPLEMENT

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.

Also known as: β-carotene; retinyl acetate

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle University: lead
• International Food Policy Research Institute: collaborator
• Penn State University: collaborator

Study Sites (1)

Newcastle University

Newcastle upon Tyne, Tyne & Wear, NE2 4HH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

retinol acetate

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Anthony Oxley, PhD

CONTACT

0191 208 1403; anthony.oxley@ncl.ac.uk

Georg Lietz, PhD

CONTACT

0191 208 6893; georg.lietz@ncl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed in two phases to allow the research team to firstly determine the absorption and bioconversion kinetics of pure βCX and provide external validation for single-sample prediction methods. The second phase aims to test the bioavailability of both pVACs in maize by comparing a high βCX:βC variety to a low βCX:βC variety in combination with external \[13C\]-labelled pVACs.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)