Vitamin A Absorption From Cassava in Women

Phase 2

Completed

• Conditions: Vitamin A Deficiency
• Interventions: 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

• Registration Number: NCT01381276
• Lead Sponsor: USDA, Western Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cassava Treatment 1	Beta-Carotene bio-fortified cassava porridge without oil	Single meal containing bio-fortified, high carotenoid cassava without oil.
Cassava Treatment 2	Beta-Carotene bio-fortified cassava porridge with oil	Single meal containing bio-fortified, high carotenoid cassava with oil.
Cassava Treatment 3	White cassava porridge with retinyl palmitate reference dose	Single meal containing low carotenoid cassava with oil and retinyl palmitate.

Primary Outcome Measures

Name	Time	Method
Vitamin A equivalency from varieties of cassava with and without oil	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.

Trial Locations

Locations (1)

Western Human Nutrition Center, University of California Davis; 🇺🇸 Davis, California, United States