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Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

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ClinicalTrials.gov Identifier: NCT02702622
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Vitamin A Deficiency Other: Provitamin A-biofortified transgenic bananas

Study Design

Study Type : Interventional  (Clinical Trial)
Study Start Date : March 2016
Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction [ Time Frame: 0 - 9.5 hours postprandially ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
More Information

Responsible Party: Wendy S. White, Associate Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT02702622     History of Changes
Other Study ID Numbers: 13-376
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Wendy S. White, Iowa State University:
vitamin A

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Deficiency Diseases
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Beta Carotene
Growth Substances
Physiological Effects of Drugs