HealthyMAIZENCT02373943
The MULTINUTRIENT Maize Project: Results of Human Feeding Trial
A study testing β-carotene biofortified maize, β-carotene supplemented maize and Normal (non biofortified) maize without added β-carotene in people with Healthy, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- β-carotene biofortified maize, β-carotene supplemented maize and Normal (non biofortified) maize without added β-carotene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy persons
- Persons who had not taken vitamin A or β-carotene supplements within the past month
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- β-carotene biofortified maize, β-carotene supplemented maize, Normal (non biofortified) maize without added β-carotene
- Keywords
- vitamin A, human, bioavailability, fortified maize, cross-over, beta-carotene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-carotene biofortified maizeOther
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
β-carotene supplemented maizeOther
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
Normal (non biofortified) maize without added β-caroteneOther
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize
| Study group | Role | What they receive |
|---|---|---|
| β-carotene biofortified maize | Experimental | 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. Receives: Other: β-carotene biofortified maize |
| white maize supplemented with β-carotene | Active comparator | 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. Receives: Other: β-carotene supplemented maize |
| white maize | Sham comparator | 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. Receives: Other: Normal (non biofortified) maize without added β-carotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of vitamin A bioavailability, as measured by the plasma all-trans retinol response, between fortified maize and wild type
Comparison of baseline corrected AUC plasma concentrations of all-trans retinol over 8h
Measured: Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h
Secondary outcomes (1)
Relative bioavailability of provitamin A in terms of fortified maize vs wild type maize supplemented with a beta-carotene reference dose.
Comparison of baseline corrected AUC plasma concentrations of all-trans retinol over 8h
Measured: Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Lleida
- Responsible party
- Principal investigator, Joan Antoni Schoenenberger, Institut de Recerca Biomèdica de Lleida
- Investigators
- Juan A Schoenenberger, Pharm D, Principal investigator, Institut de Recerca Biomèdica de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373943
- Sponsor's protocol ID
- ERCEA - PoC2013 - 619161
- Acronym
- MAIZE
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Li S, Nugroho A, Rocheford T, White WS. Vitamin A equivalence of the ss-carotene in ss-carotene-biofortified maize porridge consumed by women. Am J Clin Nutr. 2010 Nov;92(5):1105-12. doi: 10.3945/ajcn.2010.29802. Epub 2010 Sep 1.
PubMed 20810977Grune T, Lietz G, Palou A, Ross AC, Stahl W, Tang G, Thurnham D, Yin SA, Biesalski HK. Beta-carotene is an important vitamin A source for humans. J Nutr. 2010 Dec;140(12):2268S-2285S. doi: 10.3945/jn.109.119024. Epub 2010 Oct 27.
PubMed 20980645Christou P, Twyman RM. The potential of genetically enhanced plants to address food insecurity. Nutr Res Rev. 2004 Jun;17(1):23-42. doi: 10.1079/NRR200373.
PubMed 19079913Paine JA, Shipton CA, Chaggar S, Howells RM, Kennedy MJ, Vernon G, Wright SY, Hinchliffe E, Adams JL, Silverstone AL, Drake R. Improving the nutritional value of Golden Rice through increased pro-vitamin A content. Nat Biotechnol. 2005 Apr;23(4):482-7. doi: 10.1038/nbt1082. Epub 2005 Mar 27.
PubMed 15793573Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.
PubMed 25411289
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin A From β-carotene-Biofortified Maize Porridge Consumed by Women and Men: Results of a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02373943
- Acronym / sponsor ID
- MAIZE / ERCEA - PoC2013 - 619161
- Conditions
- Healthy
- Keywords
- vitamin A, human, bioavailability, fortified maize, cross-over, beta-carotene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de Recerca Biomèdica de LleidaUniversity, hospital or other
- Collaborators
- Universitat de Lleida
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| β-carotene biofortified maize | Experimental | Other: β-carotene biofortified maizeParticipants 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. |
| white maize supplemented with β-carotene | Active comparator | Other: β-carotene supplemented maizeParticipants 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. |
| white maize | Sham comparator | Other: Normal (non biofortified) maize without added β-caroteneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy persons
- Persons who had not taken vitamin A or β-carotene supplements within the past month
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β-carotene biofortified maizeDetermination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene fortified maize | Other | β-carotene biofortified maize |
| β-carotene supplemented maizeDetermination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene supplemented maize | Other | white maize supplemented with β-carotene |
| Normal (non biofortified) maize without added β-caroteneDetermination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize | Other | white maize |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Background: PubMed 20810977Li S, Nugroho A, Rocheford T, White WS. Vitamin A equivalence of the ss-carotene in ss-carotene-biofortified maize porridge consumed by women. Am J Clin Nutr. 2010 Nov;92(5):1105-12. doi: 10.3945/ajcn.2010.29802. Epub 2010 Sep 1.
- Background: PubMed 20980645Grune T, Lietz G, Palou A, Ross AC, Stahl W, Tang G, Thurnham D, Yin SA, Biesalski HK. Beta-carotene is an important vitamin A source for humans. J Nutr. 2010 Dec;140(12):2268S-2285S. doi: 10.3945/jn.109.119024. Epub 2010 Oct 27.
- Background: PubMed 19079913Christou P, Twyman RM. The potential of genetically enhanced plants to address food insecurity. Nutr Res Rev. 2004 Jun;17(1):23-42. doi: 10.1079/NRR200373.
- Background: PubMed 15793573Paine JA, Shipton CA, Chaggar S, Howells RM, Kennedy MJ, Vernon G, Wright SY, Hinchliffe E, Adams JL, Silverstone AL, Drake R. Improving the nutritional value of Golden Rice through increased pro-vitamin A content. Nat Biotechnol. 2005 Apr;23(4):482-7. doi: 10.1038/nbt1082. Epub 2005 Mar 27.
- Background: PubMed 25411289Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A Schoenenberger, Pharm D principal investigator
Institut de Recerca Biomèdica de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-carotene biofortified maize, β-carotene supplemented maize and Normal (non biofortified) maize without added β-carotene in people with Healthy, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373943, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.