InflammationNCT03451214
Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
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 different dietary zinc intakes on fatty acid metabolism and other 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, Dyslipidemias
- What is being tested?
- Diet Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jun 2018
- 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
- willing to stop zinc supplementation 4 weeks prior to start of 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
- smoker or user of nicotine products
- history of alcohol abuse, or use of illicit drugs.
- Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital Oakland Research Institute
Oakland, California, 94609
About this study
Official title: Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men
The purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers
Read the detailed description
This research is a dietary intervention study designed to evaluate the effect of progressive changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also be compared to the DNA strand breaks. In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia. Similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.
- Conditions
- Inflammation, Oxidative Stress, Dyslipidemias
- Being tested
- Diet Zinc
- Medical subject headings
- Inflammation, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet ZincOther
4 mg zinc from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period
| Study group | Role | What they receive |
|---|---|---|
| diet zinc | Experimental | 3 dietary zinc levels: 6 mg/d, 11 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.
Lipidomics changes
Change in Fatty acid metabolism
Measured: Day 0, day 15, day 57 and day 71
DNA strand breaks changes
change in COMET assay olive-tail moments
Measured: Day 0, day 15, day 57 and day 71
Secondary outcomes (4)
Polar Metabolomics changes
Change in Polar Metabolomics
Measured: Day 0, day 15, day 57 and day 71
Mineral analysis changes
Changes in Plasma Zinc
Measured: Day 0, day 15, day 57 and day 71
Body weight changes
changes in Body weight
Measured: Day 0, day 15, day 57 and day 71
Fat allocation changes
Changes in waist circumference
Measured: Day 0, day 15, day 57 and day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Suh, PhD, Principal investigator, Associate Staff Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451214
- Sponsor's protocol ID
- CHO22
- Status last verified
- Apr 2018
- First submitted
- 9 Feb 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liong EM, McDonald CM, Suh J, Westcott JL, Wong CP, Signorell C, King JC. Zinc-Biofortified Wheat Intake and Zinc Status Biomarkers in Men: Randomized Controlled Trial. J Nutr. 2021 Jul 1;151(7):1817-1823. doi: 10.1093/jn/nxab092.
PubMed 34036355
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men
- ClinicalTrials.gov ID
- NCT03451214
- Acronym / sponsor ID
- CHO22
- Conditions
- Inflammation, Oxidative Stress, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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 different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers
Detailed description
This research is a dietary intervention study designed to evaluate the effect of progressive changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also be compared to the DNA strand breaks. In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia. Similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.
Study design
- Primary purpose
- Basic science
- 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, 11 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 (5 listed)
- willing to limit food and beverage intake to that provided by the study
- willing to discontinue consumption of alcoholic beverages during the study
- willing to stop zinc supplementation 4 weeks prior to start of the study
- has an operative understanding of English
- no plans to move from the area during the study period
Key exclusion criteria (4 listed)
- Chronic or acute metabolic disease
- smoker or user of nicotine products
- history of alcohol abuse, or use of illicit drugs.
- Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2.
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 from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period | Other | diet zinc |
Primary outcome
Lipidomics changes
Time frame: Day 0, day 15, day 57 and day 71
Change in Fatty acid metabolism
DNA strand breaks changes
Time frame: Day 0, day 15, day 57 and day 71
change in COMET assay olive-tail moments
4 secondary outcomes
Polar Metabolomics changes
Time frame: Day 0, day 15, day 57 and day 71
Mineral analysis changes
Time frame: Day 0, day 15, day 57 and day 71
Body weight changes
Time frame: Day 0, day 15, day 57 and day 71
Fat allocation changes
Time frame: Day 0, day 15, day 57 and day 71
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 14 Aug 2018.
- Derived from this study: PubMed 34036355Liong EM, McDonald CM, Suh J, Westcott JL, Wong CP, Signorell C, King JC. Zinc-Biofortified Wheat Intake and Zinc Status Biomarkers in Men: Randomized Controlled Trial. J Nutr. 2021 Jul 1;151(7):1817-1823. doi: 10.1093/jn/nxab092.
- 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.
Jung Suh, PhD principal investigator
Associate Staff Scientist
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 5 inclusion and 4 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 14 Aug 2018. 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?
Lipidomics changes (time frame: Day 0, day 15, day 57 and day 71). The study lists 2 primary outcomes in all. 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 NCT03451214, 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 14 Aug 2018.