Clinical trial NCT01381276: Vitamin A Absorption From Cassava in Women
Official title: Vitamin A Equivalence of Carotenoids From Cassava in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin A Deficiency
Keywords: Vitamin A
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: HarvestPlus
First posted: 2011-06-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* non-smoking
* BMI between 18-30
* total cholesterol concentrations between 90 and 225 mg/dL
* blood pressure under 140/90 mm Hg
* hemoglobin above 11.5 g/dL
* blood chemistries within the normal range

Exclusion Criteria:

* must not be pregnant or trying to get pregnant
* must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
* must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
* must not have blood chemistry or health history results consistent with acute cancer or heart disease
* no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
* must not be allergic to cassava, peanuts, or peanut oil

Primary outcomes:
measure: Vitamin A equivalency from varieties of cassava with and without oil
timeFrame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Western Human Nutrition Center, University of California Davis
state: California
Study officials:
affiliation: WHNRC, ARS, University of California Davis
name: Betty J Burri, PhD
role: PRINCIPAL_INVESTIGATOR
References: