- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702622
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
August 29, 2016 updated by: Wendy S. White, Iowa State University
The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction
Time Frame: 0 - 9.5 hours postprandially
|
0 - 9.5 hours postprandially
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 8, 2016
Study Record Updates
Last Update Posted (Estimate)
August 31, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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