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Completed

NCT Number: NCT01381276

Vitamin A Absorption From Cassava in Women

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beta-Carotene bio-fortified cassava porridge without oil

Other

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

Beta-Carotene bio-fortified cassava porridge with oil

Other

300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.

White cassava porridge with retinyl palmitate reference dose

Other

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.

Primary outcomes

  1. Vitamin A equivalency from varieties of cassava with and without oil

    Time frame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min

    Vitamin 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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • HarvestPlus

Registry information

Official study title

Vitamin A Equivalence of Carotenoids From Cassava in Women

Acronym: FL-80

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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