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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02210507
Enrollment
10
Registered
2014-08-06
Start date
2014-07-31
Completion date
2014-12-31
Last updated
2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Deficiency

Keywords

vitamin A, retinol, carotenoids

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.

Interventions

OTHERBiofortified cassava gari

Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).

OTHERWhite cassava gari

Non-biofortified (white) cassava and a retinyl palmitate reference dose.

OTHERWhite cassava gari + red palm oil

Non-biofortified (white) cassava gari containing red palm oil.

Sponsors

HarvestPlus
CollaboratorOTHER
USDA, Western Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma2, 3.5, 5, 7.25, and 9.5 hours after a mealVitamin 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

MeasureTime frameDescription
Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma2, 3.5, 5, 7.25, and 9.5 hours after a mealCarotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026