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

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.

Study Overview

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Davis, California, United States, 95616
        • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Betty J Burri, PhD, USDA, ARS, Western Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

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.

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