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An Evaluation of Zinc Status Biomarkers

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ClinicalTrials.gov Identifier: NCT02861352
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Janet King, UCSF Benioff Children's Hospital Oakland

Brief Summary:
The purpose of this study is to determine the effect of a moderate decrease in dietary zinc on DNA strand breaks and other cellular zinc biomarkers.

Condition or disease Intervention/treatment Phase
Inflammation Oxidative Stress Other: Diet zinc Not Applicable

Detailed Description:
Assessing the zinc status of humans has proven to be difficult because of the unique physiological features of zinc homeostasis. Animal and human studies show that a small, vulnerable pool of cellular zinc is sensitive to changes in dietary zinc. The protein, Metallothionein (MT), is made within cells to stabilize this transient zinc pool and to provide a means to 'park' a small zinc reserve. The overall goal is to develop a new method for measuring MT in cells and to assess other cellular responses to changes in small changes in dietary zinc. Culture models of zinc deficiency and excess have been developed and used to test the response of cellular MT levels and mineralization to changes in zinc availability. In Phase II, the changes in the expression of leukocytic zinc transporters and the cellular in vitro uptake of isotopic zinc will be measured. Healthy men will be recruited to participate in a 6-week feeding trial to be followed by a 3-week recovery period. The results of this study will determine if potential new cellular zinc biomarkers respond to changes in zinc status when the men are fed an additional 4 mg zinc/d incorporated into a rice-based meal. These findings will provide essential, new information for designing an efficacy trial of biofortified rice and the zinc status of infants and young children.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials
Study Start Date : March 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: diet zinc
3 dietary zinc levels: 6 mg/d, 10 mg/d and 25 mg supplemental zinc/d
Other: Diet zinc
4 mg zinc, as zinc sulfate, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period when an ad lib diet was consumed




Primary Outcome Measures :
  1. Change in the percent of leukocytic DNA strand breaks [ Time Frame: Change in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zinc ]
    Baseline measurements were made upon entry into the study. Subsequent measurements were made after 2 weeks on a low zinc diet (6 mg/d), 4 weeks on a moderate zinc intake (10 mg/d) and after 3 weeks of consuming a 25 mg zinc supplement.


Secondary Outcome Measures :
  1. Cellular zinc biomarkers [ Time Frame: At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks. ]
    Specific measurements included the gene expression of zinc transporters, the in vitro uptake of leukocytic radioactive Zn, and a comprehensive serum metabolomic and proteomic analysis.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • willing to limit food and beverage intake to that provided by the study
  • willing to discontinue consumption of alcoholic beverages during the study
  • has an operative understanding of English
  • no plans to move from the area during the study period

Exclusion Criteria:

  • chronic or acute metabolic disease (i.e., diabetes or asthma)
  • taking medications for a metabolic disorder
  • evidence of alcohol abuse or use of illicit drugs

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): NCT02861352


Locations
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United States, California
Children's Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Investigators
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Principal Investigator: Janet C King, Ph.D. UCSF Benioff Children's Hospital Oakland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janet King, Senior Scientist, UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT02861352    
Other Study ID Numbers: CHO14
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Janet King, UCSF Benioff Children's Hospital Oakland:
Zinc
DNA Integrity
Gene Expression
diet zinc
nutrition requirements
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes