The MULTINUTRIENT Maize Project: Results of Human Feeding Trial (MAIZE)

March 24, 2016 updated by: Joan Antoni Schoenenberger, Institut de Recerca Biomèdica de Lleida

Bioavailability of Vitamin A From β-carotene-Biofortified Maize Porridge Consumed by Women and Men: Results of a Randomized Crossover Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • LLeida, Spain, 25110
        • Hospital Universitari Arnau de Vilanova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy persons
  • Persons who had not taken vitamin A or β-carotene supplements within the past month

Exclusion Criteria:

  • Current or recent (previous 12 mo) cigarette smoking
  • Frequent consumption of alcoholic beverages (1 drink/d)
  • Current or recent (previous 1 mo) use of dietary supplements
  • Current or recent (previous 6 mo) use of hormonal contraceptives
  • Current or recent (previous 1 mo) use of medications known to affect lipid metabolism.
  • History of restrictive eating
  • BMI under 20 or over 30
  • Lactose intolerance
  • Vegetarians.
  • Severe or symptomatic cardiac disease or hypertension
  • History of bleeding disorders
  • Chronic history of gastric, intestinal, liver, pancreatic, or renal disease
  • Any portion of the stomach or the intestine removed (other than an appendectomy)
  • History of intestinal obstruction, malabsorption, or use of antacid drugs; cancer (active or use of medications for a history of cancer treatment within the past 5 y)
  • History of chronic alcoholism
  • History of convulsive disorder
  • Evidence of active drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recerca Biomèdica de Lleida

Collaborators

Universitat de Lleida

Investigators

  • Principal Investigator: Juan A Schoenenberger, Pharm D, Institut de Recerca Biomèdica de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 15, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCEA - PoC2013 - 619161

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.

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