Vitamin A Absorption From Cassava in Women

Vitamin A Deficiency Clinical Trial

— FL-80  

Official title:

Vitamin A Equivalence of Carotenoids From Cassava in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381276
• Other study ID #: WHNRC 223773-1
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2011
• Last updated: December 8, 2011
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Western Human Nutrition Center, University of California Davis	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	HarvestPlus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No