Assessment of Vitamin B12 Bioavailability From Egg
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Purpose
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.
| Condition |
|---|
|
Bioavailability of Vitamin B12 From Chicken Eggs |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Assessment of Vitamin B12 Bioavailability From Egg |
- Fecal enrichment of 14C [ Time Frame: Over the course of 8 days after dosing with 14C labeled egg ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Plasma, serum, buffy coat, urine, stool
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Healthy adults, 18 y or older
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.
Contacts and Locations| United States, California | |
| Usda, Ars, Whnrc | |
| Davis, California, United States, 95616 | |
| Principal Investigator: | Linday H Allen, PhD | ARS, USDA, WHNRC |
| Study Chair: | Marjorie G Garrod, PhD | ARS, USDA, WHNRC |
More Information
No publications provided
| Responsible Party: | Lindsay H. Allen, ARS USDA WHNRC |
| ClinicalTrials.gov Identifier: | NCT01366937 History of Changes |
| Other Study ID Numbers: | 200715660-2 |
| Study First Received: | January 16, 2009 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by USDA, Western Human Nutrition Research Center:
|
vitamin B12 egg 14C fecal excretion |
Additional relevant MeSH terms:
|
Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013