Zinc DeficiencyNCT01221129
Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
An observational study of Zinc Deficiency, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Acclimation, Dietary zinc depletion and Dietary zinc repletion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: UF campus community
Who may be able to join
- Healthy male
- 21-35 years
- Body weight above 110 lb
Who cannot join
- Use of dietary supplements
- Smoker
- Alcoholic
- Under medication
- History of chronic disease
- Use of denture cream
- Vegetarian
- Food allergy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Zinc Deficiency
- Being tested
- Acclimation, Dietary zinc depletion, Dietary zinc repletion
- Keywords
- zinc, reticulocyte, PBMC, whole blood, transcriptome, microarray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcclimationOther
Also called Adaptation, Phase 1
11 mg Zn/day as a controlled intake level
Dietary zinc depletionOther
Also called Phase 2
< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content
Dietary zinc repletionOther
Also called Phase 3
15 mg Zn/day as a daily supplement plus normal habitual diet without restriction
| Study group | Role | What they receive |
|---|---|---|
| Dietary Restriction | Not described Receives: Other: Acclimation; Other: Dietary zinc depletion; Other: Dietary zinc repletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum zinc concentration
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Cousins, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221129
- Sponsor's protocol ID
- UF-GCRC-772
- Other IDs
- R01DK031127
- Status last verified
- Sep 2011
- First submitted
- 13 Oct 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22456662
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
- ClinicalTrials.gov ID
- NCT01221129
- Acronym / sponsor ID
- UF-GCRC-772
- Conditions
- Zinc Deficiency
- Keywords
- zinc, reticulocyte, PBMC, whole blood, transcriptome, microarray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Restriction | – | Other: Acclimation, Other: Dietary zinc depletion, Other: Dietary zinc repletion |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- UF campus community
Key inclusion criteria (3 listed)
- Healthy male
- 21-35 years
- Body weight above 110 lb
Key exclusion criteria (8 listed)
- Use of dietary supplements
- Smoker
- Alcoholic
- Under medication
- History of chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcclimationAlso: Adaptation, Phase 111 mg Zn/day as a controlled intake level | Other | Dietary Restriction |
| Dietary zinc depletionAlso: Phase 2< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content | Other | Dietary Restriction |
| Dietary zinc repletionAlso: Phase 315 mg Zn/day as a daily supplement plus normal habitual diet without restriction | Other | Dietary Restriction |
Primary outcome
Serum zinc concentration
Time frame: 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Derived from this study: PubMed 22456662Ryu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Cousins, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zinc Deficiency, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum zinc concentration (time frame: 24 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.