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Completed

NCT Number: NCT01221129

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

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.

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Key information

Conditions

Zinc Deficiency

Age range

21 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 23611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acclimation

Other

11 mg Zn/day as a controlled intake level

Other names: Adaptation, Phase 1

Dietary zinc depletion

Other

< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content

Other names: Phase 2

Dietary zinc repletion

Other

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

Other names: Phase 3

Primary outcomes

  1. Serum zinc concentration

    Time frame: 24 days

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 14, 2010
Registry last updated
Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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