NCT02373943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

February 15, 2015

Last Update Submit

March 24, 2016

Conditions

Healthy

Keywords

vitamin Ahumanbioavailabilityfortified maizecross-overbeta-carotene

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Relative bioavailability of provitamin A in terms of fortified maize vs wild type maize supplemented with a beta-carotene reference dose.

    Pharmacokinetic measures: -15 min, 2h, 3.5h, 5h, 7h. 8h

Study Arms (3)

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.

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.

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.

Other: Normal (non biofortified) maize without added β-carotene

Interventions

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 biofortified 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

white maize supplemented with β-carotene
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

white maize

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, LLeida, 25110, Spain

Location

Related Publications (5)

  • 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.

    PMID: 20810977BACKGROUND

  • 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.

    PMID: 20980645BACKGROUND

  • 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.

    PMID: 19079913BACKGROUND

  • 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. doi: 10.1038/nbt1082. Epub 2005 Mar 27.

    PMID: 15793573BACKGROUND

  • 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.

    PMID: 25411289BACKGROUND

Study Officials

  • Juan A Schoenenberger, Pharm D

    Institut de Recerca Biomèdica de Lleida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Joan Antoni Schoenenberger Arnaiz

Study Record Dates

First Submitted

February 15, 2015

First Posted

February 27, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

ES(1)