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Vitamin A Absorption From Cassava in Women

NCT ID: NCT01381276

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

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.

Conditions

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Vitamin A Deficiency

Keywords

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Vitamin A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cassava Treatment 1

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

Group Type EXPERIMENTAL

Beta-Carotene bio-fortified cassava porridge without oil

Intervention Type OTHER

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

Cassava Treatment 2

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

Group Type EXPERIMENTAL

Beta-Carotene bio-fortified cassava porridge with oil

Intervention Type OTHER

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

Cassava Treatment 3

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

Group Type ACTIVE_COMPARATOR

White cassava porridge with retinyl palmitate reference dose

Intervention Type 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.

Interventions

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Beta-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.

Intervention Type OTHER

Beta-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.

Intervention Type OTHER

White 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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HarvestPlus

OTHER

Sponsor Role collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Betty J Burri, PhD

Role: PRINCIPAL_INVESTIGATOR

WHNRC, ARS, University of California Davis

Locations

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Western Human Nutrition Center, University of California Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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WHNRC 223773-1

Identifier Type: -

Identifier Source: org_study_id