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Beta-carotene Absorption and Bioconversion to Vitamin A From Biofortified Cassava Gari

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ClinicalTrials.gov Identifier: NCT02210507
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Study Description
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Brief Summary:
The goal of the research study is to determine the absorption, metabolism, and bioconversion of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava compared to a mixture of red palm oil and gari made from typical white cassava.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Other: Biofortified cassava gari Other: White cassava gari Other: White cassava gari + red palm oil Not Applicable

Detailed Description:

Vitamin A deficiency (VAD) is a major public health problem in most of the developing world, especially Southern Asia and Sub-Saharan Africa. The primary issue in vitamin A deficient populations is the low vitamin A content of the diet. Beta-carotene is the most abundant provitamin A carotenoid in nature and in human tissues. Increasing the concentrations of bioavailable vitamin A-forming carotenoids in staple foods by selective breeding is a good strategy for improving vitamin A status. Cassava, bred to contain high amounts of vitamin A-forming carotenoids is one such food, since it is a staple crop in Africa and parts of South America. A popular cassava product Africa is gari, which is fermented, dewatered, milled, and roasted so that it can be used for porridges and in baking. However, the effect of feeding biofortified gari meals on carotenoid and vitamin A concentrations in the body is not known. A common practice is to add red palm oil to typical white cassava gari. Red palm oil is a very rich source of alpha-carotene and beta-carotene, in highly bioavailable forms. Unfortunately, little is known of the bioconversion of red palm oil cassava mixture carotenoids to vitamin A.

The primary purpose of this study is to determine the effect of consuming gari that is made from biofortified cassava on carotenoid and vitamin A concentrations. The investigators will compare carotenoid and vitamin A concentrations in individuals fed biofortified gari to the same individuals fed gari made from ordinary cassava. The investigators hypothesis is that the biofortified gari will increase carotenoid and vitamin A concentrations in triacylglycerol-rich plasma (TRL). The secondary purpose of this study is to investigate the effect of a meal of high carotenoid red palm oil added to typical white gari on carotenoids and vitamin A. Adding red palm oil to white gari should be an effective method for increasing carotenoids and vitamin A status in the gari meal, and thus humans. The investigators will match the amount of retinol equivalents in the biofortified cassava gari and red palm oil-containing white cassava gari. This will let us compare their effectiveness at increasing carotenoid and vitamin A concentrations in the TRL plasma fraction after consumption. This will allow us to compare their bioavailability and bioconversion efficiencies.

Study Design
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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: Beta-carotene Absorption and Bioconversion to Vitamin A in a Biofortified Cassava Gari Meal and a White Cassava Gari Meal With Added Red Palm Oil
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arms and Interventions
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Arm Intervention/treatment
Experimental: White cassava gari
A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
 Other: White cassava gari
Non-biofortified (white) cassava and a retinyl palmitate reference dose.
Experimental: White cassava gari + red palm oil
A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.
 Other: White cassava gari + red palm oil
Non-biofortified (white) cassava gari containing red palm oil.
Experimental: Biofortified cassava gari
A single meal containing 400 gm of garified biofortified cassava.
 Other: Biofortified cassava gari
Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).


Outcome Measures
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Primary Outcome Measures :
  1. Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma [ Time Frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal ]
    Vitamin A is measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase high pressure liquid chromatography (HPLC) using electrochemical detection.


Secondary Outcome Measures :
  1. Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma [ Time Frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal ]
    Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.


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:

  • healthy
  • non-pregnant, non-lactating
  • premenopausal women
  • non-smoking
  • body mass index between 18 and 35
  • total cholesterol concentrations between 90 and 225 mg/dL
  • blood pressure under 140/90 mm Hg

Exclusion Criteria:

  • anemia, Hemoglobin less than 11.5 g/dL
  • medications such as gemfibrozil, niacin, lovastatin, simvastatin, ezetimibe)
  • medications that affect retinoid or carotenoid metabolism (Accutane)
  • medications that impair fat absorption (Xenical, orlistat)
  • dietary supplements containing vitamin A
Contacts and Locations
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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): NCT02210507


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

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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02210507    
Other Study ID Numbers: FL93
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015
Keywords provided by USDA, Western Human Nutrition Research Center:
vitamin A
retinol
carotenoids
Additional relevant MeSH terms:
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Night Blindness
Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
 Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases