Assessment of Vitamin B12 Bioavailability From Egg

August 3, 2011 updated by: USDA, Western Human Nutrition Research Center

The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and fed to healthy human subjects to determine B12 bioavailability from eggs.

The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to a level that allows us to feed the enriched eggs to humans and determine how much of the vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful to animals or humans. The results of the investigators first experiment indicate that the investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a bioavailability study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

10

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

  • United States
    • California
      • Davis, California, United States, 95616
        • USDA, ARS, WHNRC

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults, 18 y or older

Description

Inclusion Criteria:

  • normal healthy subjects, adequate B12 status and absorptive capacity and the availability to complete the protocol.

Exclusion Criteria:

  • any chronic health disorder, anemia of any kind, renal insufficiency, and pregnancy or lactation.

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

  • Observational Models: Case-Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal enrichment of 14C
Time Frame: Over the course of 8 days after dosing with 14C labeled egg
Over the course of 8 days after dosing with 14C labeled egg

Collaborators and Investigators

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

Sponsor

USDA, Western Human Nutrition Research Center

Investigators

  • Principal Investigator: Linday H Allen, PhD, ARS, USDA, WHNRC
  • Study Chair: Marjorie G Garrod, PhD, ARS, USDA, WHNRC

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

August 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200715660-2

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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