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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221129
• Other study ID #: UF-GCRC-772
• Secondary ID: R01DK031127
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: September 16, 2011
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 35 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Other:
• Acclimation
11 mg Zn/day as a controlled intake level
• Dietary zinc depletion
< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content
• Dietary zinc repletion
15 mg Zn/day as a daily supplement plus normal habitual diet without restriction

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum zinc concentration		24 days	No