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

This study has been completed.
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01381276
First received: June 22, 2011
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Vitamin A Equivalence of Carotenoids From Cassava in Women

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Vitamin A equivalency from varieties of cassava with and without oil [ Time Frame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01381276     History of Changes
Other Study ID Numbers: WHNRC 223773-1
Study First Received: June 22, 2011
Last Updated: December 8, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

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
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014