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

Primary Purpose

Vitamin A Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofortified cassava gari
White cassava gari
White cassava gari + red palm oil
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin A Deficiency focused on measuring vitamin A, retinol, carotenoids

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • USDA, ARS, Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

White cassava gari

White cassava gari + red palm oil

Biofortified cassava gari

Arm Description

A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.

A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.

A single meal containing 400 gm of garified biofortified cassava.

Outcomes

Primary Outcome Measures

Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
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

Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.

Full Information

First Posted
August 1, 2014
Last Updated
January 9, 2015
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
HarvestPlus
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1. Study Identification

Unique Protocol Identification Number
NCT02210507
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
HarvestPlus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
vitamin A, retinol, carotenoids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
White cassava gari
Arm Type
Experimental
Arm Description
A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
Arm Title
White cassava gari + red palm oil
Arm Type
Experimental
Arm Description
A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.
Arm Title
Biofortified cassava gari
Arm Type
Experimental
Arm Description
A single meal containing 400 gm of garified biofortified cassava.
Intervention Type
Other
Intervention Name(s)
Biofortified cassava gari
Intervention Description
Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
Intervention Type
Other
Intervention Name(s)
White cassava gari
Intervention Description
Non-biofortified (white) cassava and a retinyl palmitate reference dose.
Intervention Type
Other
Intervention Name(s)
White cassava gari + red palm oil
Intervention Description
Non-biofortified (white) cassava gari containing red palm oil.
Primary Outcome Measure Information:
Title
Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Description
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.
Time Frame
2, 3.5, 5, 7.25, and 9.5 hours after a meal
Secondary Outcome Measure Information:
Title
Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
Description
Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.
Time Frame
2, 3.5, 5, 7.25, and 9.5 hours after a meal

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty J Burri, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ars.usda.gov/Main/docs.htm?docid=11240
Description
USDA, ARS, WHNRC

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

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