Vitamin A Absorption From Cassava in Women

NCT01381276 | Completed Phase 2 DMC

• 1 other identifier: WHNRC 223773-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin A Deficiency

Keywords

Vitamin A

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Cassava Treatment 1

EXPERIMENTAL

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

Other: Beta-Carotene bio-fortified cassava porridge without oil

Cassava Treatment 2

EXPERIMENTAL

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

Other: Beta-Carotene bio-fortified cassava porridge with oil

Cassava Treatment 3

ACTIVE COMPARATOR

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

Other: White cassava porridge with retinyl palmitate reference dose

Interventions

Beta-Carotene bio-fortified cassava porridge without oil OTHER

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

Cassava Treatment 1

Beta-Carotene bio-fortified cassava porridge with oil OTHER

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

Cassava Treatment 2

White cassava porridge with retinyl palmitate reference dose 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.

Cassava Treatment 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• HarvestPlus: collaborator

Study Sites (1)

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

Oils

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

• Betty J Burri, PhD

  WHNRC, ARS, University of California Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 12, 2011

Record last verified: 2011-12

Locations

US (1)