Clinical Trials Directory

Trials / Completed

CompletedNCT01221129

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

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
University of Florida · Academic / Other
Sex
Male
Age
21 Years – 35 Years
Healthy volunteers
Accepted

Summary

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.

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).

Conditions

Interventions

TypeNameDescription
OTHERAcclimation11 mg Zn/day as a controlled intake level
OTHERDietary zinc depletion\< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content
OTHERDietary zinc repletion15 mg Zn/day as a daily supplement plus normal habitual diet without restriction

Timeline

Start date
2009-10-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2010-10-14
Last updated
2011-09-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01221129. Inclusion in this directory is not an endorsement.