Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

Vitamin A Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702622
• Other study ID #: 13-376
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: August 29, 2016
• Start date: March 2016

Study information

• Verified date: August 2016
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-availability Study

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• Provitamin A-biofortified transgenic bananas

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction		0 - 9.5 hours postprandially