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Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

Primary Purpose

Vitamin A Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Provitamin A-biofortified transgenic bananas
Sponsored by
Iowa State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Vitamin A Deficiency focused on measuring bananas, biofortified, carotenoids, vitamin A

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • General good health as determined by interview, blood biochemistry profile, and complete blood count
  • Antecubital veins amenable to blood collection

Exclusion Criteria:

  • Adverse reactions to blood sample collection
  • History of anemia or excessive bleeding
  • Cigarette smoking, frequent alcohol consumption
  • Use of vitamin/mineral supplements
  • Food allergies
  • Lactose intolerance
  • Abnormal thyroid status
  • Chronic disease, lipid malabsorption or gastrointestinal disorders
  • Hyper- or hypolipidemia
  • Body mass index (BMI) > 28
  • History of eating disorder or restrained eating
  • Current or planned pregnancy; menstrual cycle irregularities or abnormalities
  • Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2016
    Last Updated
    August 29, 2016
    Sponsor
    Iowa State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02702622
    Brief Title
    Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Iowa State University

    4. Oversight

    5. Study Description

    Brief Summary
    The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin A Deficiency
    Keywords
    bananas, biofortified, carotenoids, vitamin A

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Provitamin A-biofortified transgenic bananas
    Primary Outcome Measure Information:
    Title
    Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction
    Time Frame
    0 - 9.5 hours postprandially

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: General good health as determined by interview, blood biochemistry profile, and complete blood count Antecubital veins amenable to blood collection Exclusion Criteria: Adverse reactions to blood sample collection History of anemia or excessive bleeding Cigarette smoking, frequent alcohol consumption Use of vitamin/mineral supplements Food allergies Lactose intolerance Abnormal thyroid status Chronic disease, lipid malabsorption or gastrointestinal disorders Hyper- or hypolipidemia Body mass index (BMI) > 28 History of eating disorder or restrained eating Current or planned pregnancy; menstrual cycle irregularities or abnormalities Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport

    12. IPD Sharing Statement

    Learn more about this trial

    Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

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