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Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221129
First Posted: October 14, 2010
Last Update Posted: September 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida
  Purpose
The specific aim of this protocol is to examine differential expression of specific mRNAs and proteins that occur when the dietary intake of zinc is acutely reduced below the dietary requirement for a period of ten days.

Condition Intervention
Zinc Deficiency Other: Acclimation Other: Dietary zinc depletion Other: Dietary zinc repletion

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Serum zinc concentration [ Time Frame: 24 days ]

Biospecimen Retention:   Samples With DNA
Blood cells in clotted blood

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dietary Restriction Other: Acclimation
11 mg Zn/day as a controlled intake level
Other Names:
  • Adaptation
  • Phase 1
Other: Dietary zinc depletion
< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content
Other Name: Phase 2
Other: Dietary zinc repletion
15 mg Zn/day as a daily supplement plus normal habitual diet without restriction
Other Name: Phase 3

Detailed Description:

Methods to assess the dietary zinc status of individual humans or populations are lacking. The study is a three period observational study of biomarkers of zinc status before, during and after zinc depletion. The entire dietary study will take 24 days composed of three parts:

  • Dietary Acclimation (Phase 1): 7 days
  • Dietary Zinc Restriction (Phase 2): 10 days
  • Dietary Zinc Repletion (Phase 3): 7 days

The dietary treatments and all blood draws will be carried out in the General Clinical Research Center (GCRC) at University of Florida. Previous research from has shown that both metallothionein gene expression and specific zinc transporter genes in blood leukocyte subsets are directly proportional to dietary zinc intake. By using cDNA array analysis and quantitative PCR technology with blood RNA, those genes most sensitive to zinc nutrition will be identified for the purpose of developing zinc status assessment methods on how zinc functions in human biology.

Additionally, buccal mucosal cells will be collected in the GCRC by using swabs, i.e., in a noninvasive manner, to further characterize the expression pattern of the genes under study. This method has the potential for nutrition studies in the field (international nutrition, etc).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
UF campus community
Criteria

Inclusion Criteria:

  • Healthy male
  • 21-35 years
  • Body weight above 110 lb

Exclusion Criteria:

  • Use of dietary supplements
  • Smoker
  • Alcoholic
  • Under medication
  • History of chronic disease
  • Use of denture cream
  • Vegetarian
  • Food allergy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221129


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 23611
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Robert J Cousins, Ph.D. University of Florida
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01221129     History of Changes
Other Study ID Numbers: UF-GCRC-772
R01DK031127 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2010
First Posted: October 14, 2010
Last Update Posted: September 20, 2011
Last Verified: September 2011

Keywords provided by University of Florida:
zinc
reticulocyte
PBMC
whole blood
transcriptome
microarray

Additional relevant MeSH terms:
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs