NCT02702622

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

March 3, 2016

Last Update Submit

August 29, 2016

Conditions

Vitamin A Deficiency

Keywords

bananasbiofortifiedcarotenoidsvitamin A

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction

    0 - 9.5 hours postprandially

Interventions

Provitamin A-biofortified transgenic bananasOTHER

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • General good health as determined by interview, blood biochemistry profile, and complete blood count
  • Antecubital veins amenable to blood collection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08