The MULTINUTRIENT Maize Project: Results of Human Feeding Trial (MAIZE)
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|ClinicalTrials.gov Identifier: NCT02373943|
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : March 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: β-carotene biofortified maize Other: β-carotene supplemented maize Other: Normal (non biofortified) maize without added β-carotene||Not Applicable|
Human feeding trial with fortified maize is part of the BIOFORCE project which aims to create transgenic cereal plants that will provide a near complete micronutrient complement for malnourished people. β-Carotene intake helps to balance inadequate retinol supply in significant parts of the world. In order for plants with enhanced levels of micronutrients to be useful, the micronutrients must be present in a bioavailable form that can be absorbed by the human body. To test the main hypothesis of the trial an open-label, randomized, three-way crossover trial consisting of three 7-day feeding periods has been designed. The study will compare three different feeding conditions: β-carotene fortified maize containing diet, white maize containing diet supplemented with a reference β-carotene dose and white maize diet. The study will test the hypothesis that a meal including fortified maize yields superior all-trans retinol area under the plasma concentration versus time curve (AUC) values than an isocaloric and isoprotein meal with normal maize.
After a first screen that will address physical conditions and lifestyle 18 volunteers (9 men and 9 women) who meet the eligibility criteria will be included in the study once they have read and sign the informed consent. The postprandial plasma all-trans retinol response to each test meal will be used to establish the bioavailability of provitamin A from fortified maize. The test meals will be consumed in random order separated by 1 week. Blood samples will be collected over 8 h. All-trans retinol will be analyzed in plasma by high pressure liquid chromatography (HPLC) with coulometric array electrochemical detection.
Mean AUC for all-trans retinol in plasma after ingestion of the β-carotene-fortified maize porridge, the white maize porridge with the β-carotene reference dose, and the white maize porridge will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioavailability of Vitamin A From β-carotene-Biofortified Maize Porridge Consumed by Women and Men: Results of a Randomized Crossover Trial|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: β-carotene biofortified maize
Participants will ingest porridge bF: this will be the β-carotene fortified maize porridge where each 250 g will be made with 50 g of dry maize flour obtained from fortified corn seeds. The contents of β-carotene and other provitamin A carotenoids in this flour will be determined before preparing the porridges.
Other: β-carotene biofortified maize
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene fortified maize
Active Comparator: white maize supplemented with β-carotene
Participants will ingest porridge F: this will be also a β-carotene fortified maize porridge but in this case it will be made with 50 g of dry maize flour obtained from non fortified corn seeds and supplemented with a 500-1500 µg β-carotene reference dose. The exact dose of β-carotene that will be added to these porridges will be established according to the amount of β-carotene found in the flour used with porridges BF.
Other: β-carotene supplemented maize
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene supplemented maize
Sham Comparator: white maize
Participants will ingest porridge N which will be the control porridge and will be made with 50 g of dry maize flour obtained from non fortified corn seeds.
Other: Normal (non biofortified) maize without added β-carotene
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize
- Comparison of vitamin A bioavailability, as measured by the plasma all-trans retinol response, between fortified maize and wild type [ Time Frame: Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h ]Comparison of baseline corrected AUC plasma concentrations of all-trans retinol over 8h
- Relative bioavailability of provitamin A in terms of fortified maize vs wild type maize supplemented with a beta-carotene reference dose. [ Time Frame: Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h ]Comparison of baseline corrected AUC plasma concentrations of all-trans retinol over 8h
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373943
|Hospital Universitari Arnau de Vilanova|
|LLeida, Spain, 25110|
|Principal Investigator:||Juan A Schoenenberger, Pharm D||Institut de Recerca Biomèdica de Lleida|