Back to resultsVitamin 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
About this trial
This is an interventional trial for Vitamin A Deficiency focused on measuring bananas, biofortified, carotenoids, vitamin A
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
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
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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