Vitamin A Absorption From Cassava in Women (FL-80)

USDA, Western Human Nutrition Research Center

Status and phase: Completed; Phase 2

Conditions: Vitamin A Deficiency

Treatments: Other: Beta-Carotene bio-fortified cassava porridge with oil; Other: White cassava porridge with retinyl palmitate reference dose; Other: Beta-Carotene bio-fortified cassava porridge without oil

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01381276

WHNRC 223773-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups

Cassava Treatment 1

Experimental group

Description:

Single meal containing bio-fortified, high carotenoid cassava without oil.

Treatment:

Other: Beta-Carotene bio-fortified cassava porridge without oil

Cassava Treatment 2

Experimental group

Description:

Single meal containing bio-fortified, high carotenoid cassava with oil.

Treatment:

Other: Beta-Carotene bio-fortified cassava porridge with oil

Cassava Treatment 3

Active Comparator group

Description:

Single meal containing low carotenoid cassava with oil and retinyl palmitate.

Treatment:

Other: White cassava porridge with retinyl palmitate reference dose