Clinical trial NCT02210507: Beta-carotene Absorption and Bioconversion to Vitamin A From Biofortified Cassava Gari
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Deficiency
Keywords: vitamin A
retinol
carotenoids
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: HarvestPlus
First posted: 2014-08-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
timeFrame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
Secondary outcomes:
measure: Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
timeFrame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Betty J Burri, PhD
role: PRINCIPAL_INVESTIGATOR
References: