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An Evaluation of Zinc Status Biomarkers

Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02861352
Enrollment
18
Registered
2016-08-10
Start date
2011-03-31
Completion date
2015-02-28
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Oxidative Stress

Keywords

Zinc, DNA Integrity, Gene Expression, diet zinc, nutrition requirements

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.

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.

Interventions

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

Sponsors

UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the percent of leukocytic DNA strand breaksChange in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zincBaseline 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

MeasureTime frameDescription
Cellular zinc biomarkersAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026