Clinical Trials Directory

Trials / Completed

CompletedNCT01381276

Vitamin A Absorption From Cassava in Women

Vitamin A Equivalence of Carotenoids From Cassava in Women

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.

Detailed description

We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.

Conditions

Interventions

TypeNameDescription
OTHERBeta-Carotene bio-fortified cassava porridge without oil300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.
OTHERBeta-Carotene bio-fortified cassava porridge with oil300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.
OTHERWhite cassava porridge with retinyl palmitate reference dose300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.

Timeline

Start date
2011-06-01
Primary completion
2011-10-01
Completion
2011-10-01
First posted
2011-06-27
Last updated
2011-12-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01381276. Inclusion in this directory is not an endorsement.