We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01221129
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : September 20, 2011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Zinc Deficiency Other: Acclimation Other: Dietary zinc depletion Other: Dietary zinc repletion

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).

Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Group/Cohort Intervention/treatment
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

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

Biospecimen Retention:   Samples With DNA
Blood cells in clotted blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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

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)
Principal Investigator: Robert J Cousins, Ph.D. University of Florida

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 Posted: October 14, 2010    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011

Keywords provided by University of Florida:
whole blood

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