InflammationNCT02861352
An Evaluation of Zinc Status Biomarkers
A study testing Diet zinc in people with Inflammation and Oxidative Stress, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress
- What is being tested?
- Diet zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Feb 2015
- Phase
- Interventional
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Oakland Research Institute
Oakland, California, 94609
About this study
Official title: Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials
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.
Read the 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.
- Conditions
- Inflammation, Oxidative Stress
- Being tested
- Diet zinc
- Keywords
- Zinc, DNA Integrity, Gene Expression, diet zinc, nutrition requirements
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet zincOther
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
| Study group | Role | What they receive |
|---|---|---|
| diet zinc | Experimental | 3 dietary zinc levels: 6 mg/d, 10 mg/d and 25 mg supplemental zinc/d Receives: Other: Diet zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zinc
Secondary outcomes (1)
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.
Measured: At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startMar 2011
- Primary completionFeb 2014
- Study completionFeb 2015
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 InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet C King, Ph.D., Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861352
- Sponsor's protocol ID
- CHO14
- Status last verified
- Nov 2020
- First submitted
- 4 Aug 2016
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zyba SJ, Shenvi SV, Killilea DW, Holland TC, Kim E, Moy A, Sutherland B, Gildengorin V, Shigenaga MK, King JC. A moderate increase in dietary zinc reduces DNA strand breaks in leukocytes and alters plasma proteins without changing plasma zinc concentrations. Am J Clin Nutr. 2017 Feb;105(2):343-351. doi: 10.3945/ajcn.116.135327. Epub 2016 Dec 21.
PubMed 28003206
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials
- ClinicalTrials.gov ID
- NCT02861352
- Acronym / sponsor ID
- CHO14
- Conditions
- Inflammation, Oxidative Stress
- Keywords
- Zinc, DNA Integrity, Gene Expression, diet zinc, nutrition requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Aug 2016 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diet zinc | Experimental | Other: Diet zinc3 dietary zinc levels: 6 mg/d, 10 mg/d and 25 mg supplemental zinc/d |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Diet zinc4 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 | Other | diet zinc |
Primary outcome
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.
1 secondary outcome
Cellular zinc biomarkers
Time frame: At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks.
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 24 Nov 2020.
- Derived from this study: PubMed 28003206Zyba SJ, Shenvi SV, Killilea DW, Holland TC, Kim E, Moy A, Sutherland B, Gildengorin V, Shigenaga MK, King JC. A moderate increase in dietary zinc reduces DNA strand breaks in leukocytes and alters plasma proteins without changing plasma zinc concentrations. Am J Clin Nutr. 2017 Feb;105(2):343-351. doi: 10.3945/ajcn.116.135327. Epub 2016 Dec 21.
- Individual participant dataSharing planned: No
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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.
Janet C King, Ph.D. principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet zinc in people with Inflammation and Oxidative Stress, run by UCSF Benioff Children's Hospital Oakland 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 4 inclusion and 3 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 24 Nov 2020. 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?
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). 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 NCT02861352, 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 24 Nov 2020.