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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01221129
First received: October 13, 2010
Last updated: September 16, 2011
Last verified: September 2011
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 35 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221129

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 23611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Robert J Cousins, Ph.D. University of Florida
  More Information

No publications provided by University of Florida

Additional 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
Study First Received: October 13, 2010
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014