The MULTINUTRIENT Maize Project: Results of Human Feeding Trial

Healthy Clinical Trial

— MAIZE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373943
• Other study ID #: ERCEA - PoC2013 - 619161
• Status: Completed
• Phase: N/A
• First received: February 15, 2015
• Last updated: March 24, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Institut de Recerca Biomèdica de Lleida
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy persons

• Persons who had not taken vitamin A or ß-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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• ß-carotene biofortified maize
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of ß-carotene fortified maize
• ß-carotene supplemented maize
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of ß-carotene supplemented maize
• Normal (non biofortified) maize without added ß-carotene
Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize

Locations

Country	Name	City	State
Spain	Hospital Universitari Arnau de Vilanova	LLeida

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recerca Biomèdica de Lleida	Universitat de Lleida

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Christou 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. — View Citation

Gannon 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. — View Citation

Grune 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. — View Citation

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. — View Citation

Paine 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. Epub 2005 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h	No
Secondary	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	Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h	No