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NCT02702622 Clinical Trial

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
Secondary ID
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. completion date
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

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
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