Vitamin A Absorption From Cassava in Women

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

Detailed Description
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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.

Official Title
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Vitamin A Equivalence of Carotenoids From Cassava in Women

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Other: Beta-Carotene bio-fortified cassava porridge without oil
* Other: Beta-Carotene bio-fortified cassava porridge with oil
* Other: White cassava porridge with retinyl palmitate reference dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cassava Treatment 1<br>Single meal containing bio-fortified, high carotenoid cassava without oil. | Other: Beta-Carotene bio-fortified cassava porridge without oil<br>* 300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.<br>|
| Experimental: Cassava Treatment 2<br>Single meal containing bio-fortified, high carotenoid cassava with oil. | Other: Beta-Carotene bio-fortified cassava porridge with oil<br>* 300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.<br>|
| Active Comparator: Cassava Treatment 3<br>Single meal containing low carotenoid cassava with oil and retinyl palmitate. | Other: White cassava porridge with retinyl palmitate reference dose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin A equivalency from varieties of cassava with and without oil | 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. | 0, 60, 150, 240, 330, 420, 510, 600, 1440 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin A