Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373943
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : March 25, 2016
Sponsor:
Collaborator:
Universitat de Lleida
Information provided by (Responsible Party):
Joan Antoni Schoenenberger, Institut de Recerca Biomèdica de Lleida

Brief 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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Spain
Hospital Universitari Arnau de Vilanova
LLeida, Spain, 25110
Sponsors and Collaborators
Institut de Recerca Biomèdica de Lleida
Universitat de Lleida
Investigators
Layout table for investigator information
Principal Investigator: Juan A Schoenenberger, Pharm D Institut de Recerca Biomèdica de Lleida
Publications:
Layout table for additonal information
Responsible Party: Joan Antoni Schoenenberger, Dr. Joan Antoni Schoenenberger Arnaiz, Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT02373943    
Other Study ID Numbers: ERCEA - PoC2013 - 619161
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Keywords provided by Joan Antoni Schoenenberger, Institut de Recerca Biomèdica de Lleida:
vitamin A
human
bioavailability
fortified maize
cross-over
beta-carotene
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs