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

Vitamin A Equivalence of Carotenoids From Cassava in Women

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

Study Overview

• Status: Completed
• Conditions: Vitamin A Deficiency
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Western Human Nutrition Center, University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cassava Treatment 1; Single meal containing bio-fortified, high carotenoid cassava without oil.	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.
Experimental: Cassava Treatment 2; Single meal containing bio-fortified, high carotenoid cassava with oil.	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.
Active Comparator: Cassava Treatment 3; Single meal containing low carotenoid cassava with oil and retinyl palmitate.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: HarvestPlus
• Investigators: Principal Investigator: Betty J Burri, PhD, WHNRC, ARS, University of California Davis

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin A
• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Anticarcinogenic Agents; Provitamins; Beta Carotene; Carotenoids; Vitamin A; Retinol palmitate
• Other Study ID Numbers: WHNRC 223773-1