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

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ClinicalTrials.gov Identifier: NCT01381276
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : December 12, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency 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 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Vitamin A Equivalence of Carotenoids From Cassava in Women
Study Start Date : June 2011
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Vitamin A equivalency from varieties of cassava with and without oil [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381276


Locations
United States, California
Western Human Nutrition Center, University of California Davis
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
HarvestPlus
Investigators
Principal Investigator: Betty J Burri, PhD WHNRC, ARS, University of California Davis
More Information

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01381276     History of Changes
Other Study ID Numbers: WHNRC 223773-1
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by USDA, Western Human Nutrition Research Center:
Vitamin A

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Beta Carotene
Retinol palmitate
Carotenoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Provitamins