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Vitamin A Absorption From Cassava in Women

Vitamin A Equivalence of Carotenoids From Cassava in Women

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01381276
Acronym
FL-80
Enrollment
10
Registered
2011-06-27
Start date
2011-06-30
Completion date
2011-10-31
Last updated
2011-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Deficiency

Keywords

Vitamin A

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.

Interventions

OTHERBeta-Carotene bio-fortified cassava porridge without oil

300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.

OTHERBeta-Carotene bio-fortified cassava porridge with oil

300g 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 dose

300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.

Sponsors

HarvestPlus
CollaboratorOTHER
USDA, Western Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vitamin A equivalency from varieties of cassava with and without oil0, 60, 150, 240, 330, 420, 510, 600, 1440 minVitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026