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Trial record 1 of 2 for:    Iowa + banana
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Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

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: NCT02702622
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Wendy S. White, Iowa State University

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March¬†7,¬†2016)
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction [ Time Frame: 0 - 9.5 hours postprandially ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
Official Title  ICMJE Not Provided
Brief Summary The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Vitamin A Deficiency
Intervention  ICMJE Other: Provitamin A-biofortified transgenic bananas
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02702622
Other Study ID Numbers  ICMJE 13-376
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wendy S. White, Iowa State University
Study Sponsor  ICMJE Iowa State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Iowa State University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP