Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wendy S. White, Iowa State University

ClinicalTrials.gov Identifier:

NCT02702622

First received: March 3, 2016

Last updated: August 29, 2016

Last verified: August 2016

History of Changes

Purpose

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

Condition	Intervention
Vitamin A Deficiency	Other: Provitamin A-biofortified transgenic bananas


Study Type:	Interventional

Resource links provided by NLM:

MedlinePlus related topics: Vitamin A

Drug Information available for: Beta carotene Vitamin A

Genetic and Rare Diseases Information Center resources: Keratomalacia

U.S. FDA Resources

Further study details as provided by Wendy S. White, Iowa State University:

Primary Outcome Measures:

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


Study Start Date:	March 2016
Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

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
Study First Received:	March 3, 2016
Last Updated:	August 29, 2016

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


bananas biofortified carotenoids vitamin A

Additional relevant MeSH terms:


Vitamin A Deficiency Night Blindness Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders	Eye Diseases Vitamin A Beta Carotene Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017

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