The MULTINUTRIENT Maize Project: Results of Human Feeding Trial
Condition: Healthy
Study type: Interventional

Summary: 
      The main objective of this human trial is the demonstration that β-carotene in fortified
      maize has good bioavailability as a plant source of vitamin A and that when humans ingest the
      biofortified product retinol levels are higher than when they ingest non biofortified white
      maize.
    

Detailed description: 
      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.
    

Intervention name(s): β-carotene biofortified maize; β-carotene supplemented maize; Normal (non biofortified) maize without added β-carotene
Intervention type(s): Other; Other; Other
Intervention description(s): 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; 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; Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin A; human; bioavailability; fortified maize; cross-over; beta-carotene