Zinc DeficiencyNCT03619421
Zinc Supplement Before or With Food in Generally Healthy Men
A study testing Zinc supplement in people with Zinc Deficiency and Dyslipidemias, 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 influence of food consumption timing on the body's response to a zinc supplement 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
- Zinc Deficiency, Dyslipidemias, Zinc Excess
- What is being tested?
- Zinc supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2018to 15 Apr 2019
- 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 stop 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
- regularly eat breakfast
Who cannot join
- Chronic or acute metabolic disease
- smoker or user of nicotine products
- history of alcohol abuse, or use of illicit drugs (incl marijuana)
- 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: Evaluation of Zinc Supplementation Taken Prior or With Food
The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement
Read the detailed description
This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.
The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.
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.
- Conditions
- Zinc Deficiency, Dyslipidemias, Zinc Excess, Inflammation
- Being tested
- Zinc supplement
- Keywords
- zinc, nutrition, supplement, food
- Medical subject headings
- Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc supplementDietary supplement
25 mg
| Study group | Role | What they receive |
|---|---|---|
| Supplement with food | Experimental | Zinc supplement to be taken at time of breakfast consumption Receives: Dietary Supplement: Zinc supplement |
| supplement prior to food | Experimental | Zinc supplement to be taken 30-min before breakfast consumption Receives: Dietary Supplement: Zinc supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Zinc changes
Change in plasma zinc
Measured: Day 0, Day 15
Secondary outcomes (3)
Body weight changes
Body weight changes
Measured: Day 0, Day 15
Essential Fatty acid changes
Essential Fatty acid changes
Measured: Day 0, Day 15
Blood glucose changes
Blood glucose changes
Measured: Day 0, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start21 Aug 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
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 Zinc DeficiencyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 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, UCSF Benioff Children's Hospital Oakland Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619421
- Sponsor's protocol ID
- CHO23
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Massih YN, Hall AG, Suh J, King JC. Zinc Supplements Taken with Food Increase Essential Fatty Acid Desaturation Indices in Adult Men Compared with Zinc Taken in the Fasted State. J Nutr. 2021 Sep 4;151(9):2583-2589. doi: 10.1093/jn/nxab149.
PubMed 34236435
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zinc Supplementation Taken Prior or With Food
- ClinicalTrials.gov ID
- NCT03619421
- Acronym / sponsor ID
- CHO23
- Conditions
- Zinc Deficiency, Dyslipidemias, Zinc Excess, Inflammation
- Keywords
- zinc, nutrition, supplement, food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 7 Aug 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 influence of food consumption timing on the body's response to a zinc supplement
Detailed description
This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.
The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement with food | Experimental | Dietary Supplement: Zinc supplementZinc supplement to be taken at time of breakfast consumption |
| supplement prior to food | Experimental | Dietary Supplement: Zinc supplementZinc supplement to be taken 30-min before breakfast consumption |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- willing to stop 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
- regularly eat breakfast
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 (incl marijuana)
- 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 |
|---|---|---|
| Zinc supplement25 mg | Dietary supplement | Supplement with food, supplement prior to food |
Primary outcome
Plasma Zinc changes
Time frame: Day 0, Day 15
Change in plasma zinc
3 secondary outcomes
Body weight changes
Time frame: Day 0, Day 15
Essential Fatty acid changes
Time frame: Day 0, Day 15
Blood glucose changes
Time frame: Day 0, Day 15
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 1 May 2019.
- Derived from this study: PubMed 34236435Massih YN, Hall AG, Suh J, King JC. Zinc Supplements Taken with Food Increase Essential Fatty Acid Desaturation Indices in Adult Men Compared with Zinc Taken in the Fasted State. J Nutr. 2021 Sep 4;151(9):2583-2589. doi: 10.1093/jn/nxab149.
- 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
UCSF Benioff Children's Hospital Oakland Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc supplement in people with Zinc Deficiency and Dyslipidemias, 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 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 1 May 2019. 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?
Plasma Zinc changes (time frame: Day 0, Day 15). 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 NCT03619421, 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 1 May 2019.