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

NCT01221129 | Completed

• 2 other identifiers: UF-GCRC-772R01DK031127
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Zinc Deficiency

Keywords

zinc; reticulocyte; PBMC; whole blood; transcriptome; microarray

Outcome Measures

Primary Outcomes (1)

• Serum zinc concentration

  24 days

Study Arms (1)

Dietary Restriction

Other: Acclimation; Other: Dietary zinc depletion; Other: Dietary zinc repletion

Interventions

Acclimation OTHER

11 mg Zn/day as a controlled intake level

Also known as: Adaptation, Phase 1

Dietary Restriction

Dietary zinc depletion OTHER

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

Also known as: Phase 2

Dietary Restriction

Dietary zinc repletion OTHER

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

Also known as: Phase 3

Dietary Restriction

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

UF campus community

You may qualify if:

• Healthy male
• years
• Body weight above 110 lb

You may not qualify if:

• Use of dietary supplements
• Smoker
• Alcoholic
• Under medication
• History of chronic disease
• Use of denture cream
• Vegetarian
• Food allergy

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 23611, United States

Location

Related Publications (1)

• Ryu MS, Guthrie GJ, Maki AB, Aydemir TB, Cousins RJ. Proteomic analysis shows the upregulation of erythrocyte dematin in zinc-restricted human subjects. Am J Clin Nutr. 2012 May;95(5):1096-102. doi: 10.3945/ajcn.111.032862. Epub 2012 Mar 28.

  PMID: 22456662 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells in clotted blood

MeSH Terms

Interventions

Acclimatization; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert J Cousins, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

US (1)