An Evaluation of Zinc Status Biomarkers

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861352
• Other study ID #: CHO14
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Oakland Research Institute	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the percent of leukocytic DNA strand breaks	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.	Change in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zinc
Secondary	Cellular zinc biomarkers	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.	At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks.