Beta-carotene Absorption and Bioconversion to Vitamin A From Biofortified Cassava Gari
1 other identifier
interventional
10
1 country
1
Brief Summary
The goal of the research study is to determine the absorption, metabolism, and bioconversion of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava compared to a mixture of red palm oil and gari made from typical white cassava.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
1 active site
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
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 12, 2015
January 1, 2015
5 months
August 1, 2014
January 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Vitamin A is measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase high pressure liquid chromatography (HPLC) using electrochemical detection.
2, 3.5, 5, 7.25, and 9.5 hours after a meal
Secondary Outcomes (1)
Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
2, 3.5, 5, 7.25, and 9.5 hours after a meal
Study Arms (3)
White cassava gari
EXPERIMENTALA single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
White cassava gari + red palm oil
EXPERIMENTALA single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.
Biofortified cassava gari
EXPERIMENTALA single meal containing 400 gm of garified biofortified cassava.
Interventions
Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
Non-biofortified (white) cassava and a retinyl palmitate reference dose.
Non-biofortified (white) cassava gari containing red palm oil.
Eligibility Criteria
You may qualify if:
- healthy
- non-pregnant, non-lactating
- premenopausal women
- non-smoking
- body mass index between 18 and 35
- total cholesterol concentrations between 90 and 225 mg/dL
- blood pressure under 140/90 mm Hg
You may not qualify if:
- anemia, Hemoglobin less than 11.5 g/dL
- medications such as gemfibrozil, niacin, lovastatin, simvastatin, ezetimibe)
- medications that affect retinoid or carotenoid metabolism (Accutane)
- medications that impair fat absorption (Xenical, orlistat)
- dietary supplements containing vitamin A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- USDA, Western Human Nutrition Research Centerlead
- HarvestPluscollaborator
Study Sites (1)
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betty J Burri, PhD
USDA, ARS, Western Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2014
First Posted
August 6, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 12, 2015
Record last verified: 2015-01