- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02210507
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- USDA, ARS, Western Human Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: White cassava gari
A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
|
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.
|
Non-biofortified (white) cassava gari containing red palm oil.
|
Experimental: Biofortified cassava gari
A single meal containing 400 gm of garified biofortified cassava.
|
Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2, 3.5, 5, 7.25, and 9.5 hours after a meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2, 3.5, 5, 7.25, and 9.5 hours after a meal
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Betty J Burri, PhD, USDA, ARS, Western Human Nutrition Research Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL93
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin A Deficiency
-
SourseCitruslabsActive, not recruitingMood | Energy Supply; Deficiency | B12 Deficiency VitaminUnited States
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustEnrolling by invitationIron Deficiency (Without Anemia) | B12 Deficiency VitaminUnited Kingdom
-
Kansas State UniversityNational Institute for Medical Research, Tanzania; United States Department... and other collaboratorsCompletedAnemia, Iron-Deficiency | Deficiency, Vitamin A
-
Newcastle UniversityBill and Melinda Gates Foundation; Institute of Nutrition of Central America... and other collaboratorsUnknownVitamin A Deficiency | Vitamin A Toxicity | Hypervitaminosis AGuatemala, United Kingdom
-
Nottingham University Hospitals NHS TrustNorthern Care Alliance NHS Foundation Trust; Barts & The London NHS Trust; University... and other collaboratorsNot yet recruitingParesthesia | Neurologic Symptoms | B12 Deficiency Vitamin | Nitrous Oxide Abuse | Subacute Combined Cord Degeneration
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVitamin A Deficiency | Vitamin A ToxicityUnited States
-
University of California, DavisPenn State University; University of Ghana; Newcastle University; Helen Keller...CompletedAnemia | Dietary Habits | Iron Deficiency | Vitamin A Deficiency | Vitamin B 12 Deficiency | Folate Deficiency | Zinc DeficiencyGhana
-
Malaysia Palm Oil BoardUniversity of MalayaUnknownVitamin A Deficiency in ChildrenMalaysia
Clinical Trials on White cassava gari
-
Wageningen UniversityUniversity of Ibadan; International Institute for Tropical AgricultureCompletedVitamin A DeficiencyNigeria
-
Wageningen UniversityUniversity of Nairobi; European CommissionCompletedVitamin A DeficiencyKenya
-
USDA, Western Human Nutrition Research CenterHarvestPlusCompleted
-
Khon Kaen UniversityCompleted
-
Universidade Federal do Rio de JaneiroCompletedObesity | Obesity, AbdominalBrazil
-
Universidade Federal do Rio de JaneiroOswaldo Cruz Foundation; Rio de Janeiro State Research Supporting Foundation... and other collaboratorsCompletedDyslipidemia | Oxidative Stress
-
University of CoimbraCompletedCommunicationPortugal
-
National Taiwan University HospitalRecruitingHyperglycemia | Type 2 Diabetes | HyperlipidemiaTaiwan
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustCompleted
-
Organización Interprofesional Agroalimentaria de...Universidad de GranadaCompleted