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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01221129
Enrollment
10
Registered
2010-10-14
Start date
2009-10-31
Completion date
2010-03-31
Last updated
2011-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Keywords

zinc, reticulocyte, PBMC, whole blood, transcriptome, microarray

Brief 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).

Interventions

OTHERAcclimation

11 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 repletion

15 mg Zn/day as a daily supplement plus normal habitual diet without restriction

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Serum zinc concentration24 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026