HealthyNCT05597137
The Exploration of the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults
A study testing Zinc Gluconate in people with Healthy, run by The Seventh Affiliated Hospital, Southern Medical University at 1 site in China.
Trial summary
In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for 2 weeks and then take Zinc supplements for 2 weeks. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zinc Gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Aug 2023
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20-30 years from the general community were recruited to participate in the study voluntarily without underlying diseases.
Who cannot join
- Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation; Those who have taken hormones within 3 months; Have taken any drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and have had probiotic intervention within 1 month; smokers and drinkers; Uncontrollable mental disorders (including hospitalization history of mental illness); (6) Currently attending a weight loss or weight management course; prescribed diet for specific or other reasons (e.g. celiac disease); pregnant or lactating women; Patients with cardiac and renal insufficiency; Patients with other underlying diseases; Long-term constipation.
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical Unversity，the seventh affiliated hospital
Foshan, Guangdong, 528000
About this study
Official title: To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for 2 weeks and then take Zinc supplements for 2 weeks.
- Conditions
- Healthy
- Being tested
- Zinc Gluconate
- Keywords
- Zinc, gut microbiota, healthy adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc GluconateDietary supplement
Each participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | During the study period, all subjects were required to avoid a diet high in zinc in order to avoid interference with dietary zinc intake and reduce bias in the weeks 1-2. In the weeks 3-4, all subjects were started to receive zinc supplementation at the normal adult dose (zinc tablets: 1 tablet (10mg Zinc) once daily after meals), while maintaining the avoidance of high-zinc foods. Receives: Dietary Supplement: Zinc Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rDNA sequencing
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.
Measured: 14days，28 days
metabolomic analysis of serum and feces
To determine the alteration of gut microbiota after Zn supplementary.
Measured: 14days，28 days
The blood levels of Zn2+ in each study phase
The blood levels of Zn2+ would be detected on day 14 and day 28.
Measured: 14days，28 days
Number of participantswith abnormal laboratory tests results
If there are abnormal situations during the experiment that may pose significant risks to the health or safety of the participants, the research team may need to terminate the experiment to ensure participant safety. Only
Measured: 14days，28 days
The fecal Zn2+ concentration in each study phase
The fecal Zn2+ concentration would be detected on day 14 and day 28.
Measured: 14days，28 days
Secondary outcomes (21)
Total bilirubin concentration after 14days oral Zn.
change from 14days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
Direct bilirubin concentration after 14days oral Zn.
change from 14days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
Indirect bilirubin concentration after 14days oral Zn.
change from 14days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
uric acid concentration after 14days oral Zn.
change from 14days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
total triglyceride concentration after 14days oral Zn.
change from 14days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
total protein concentration after 14days oral Zn.
change from 14days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
aspartate transaminase concentration after 14days oral Zn.
change from 14days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
alanine transaminase concentration after 14days oral Zn.
change from 14days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
albumin concentration after 14days oral Zn.
change from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
total cholesterol concentration after 14days oral Zn.
change from 14days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
Urea concentration after 14days oral Zn.
change from 14 days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 14days，28 days
HDL-C concentration after 14days oral Zn.
change from 14 days in HDL-C(high density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic
Measured: 14days，28 days
LDL-C concentration after 14days oral Zn.
change from 14 days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic
Measured: 14days，28 days
Red blood cells analysis after 14days oral Zn.
change from 14days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Plateltes analysis after 14days oral Zn.
change from 14 days in Plateltes and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Neutrophil cells analysis after 14days oral Zn.
change from 14days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Eosinophil cells analysis after 14days oral Zn.
change from 14days in Eosinophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Basophil cells analysis after 14days oral Zn.
change from 14 days in Basophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Lymphocyte cells analysis after 14days oral Zn.
change from 14 days in Lymphocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Monocyte cells analysis after 14days oral Zn.
change from 14 days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
White blood cells analysis after 14days oral Zn.
change from 14 days in white blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 14days，28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Seventh Affiliated Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Chen, The Seventh Affiliated Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597137
- Sponsor's protocol ID
- (2022)--0008
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since some data may involve subject's privacy #we have no plans to share data so far# and some data may be shared later depending on the subjects's wishes.
Publications
Ackland ML, Michalczyk AA. Zinc and infant nutrition. Arch Biochem Biophys. 2016 Dec 1;611:51-57. doi: 10.1016/j.abb.2016.06.011. Epub 2016 Jun 15.
PubMed 27317042Li D, Wan M, Xue L, Zhang Z, Qiu Y, Mei F, Tang N, Yu C, Yu Y, Chen T, Ding X, Yang Q, Liu Q, Gu P, Jia W, Chen Y, Chen P. Zinc promotes microbial p-coumaric acid production that protects against cholestatic liver injury. Cell Host Microbe. 2024 Dec 11;32(12):2195-2211.e9. doi: 10.1016/j.chom.2024.11.002. Epub 2024 Nov 27.
PubMed 39610253
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
- ClinicalTrials.gov ID
- NCT05597137
- Acronym / sponsor ID
- (2022)--0008
- Conditions
- Healthy
- Keywords
- Zinc, gut microbiota, healthy adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Seventh Affiliated Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 27 Oct 2022 (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.
In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for 2 weeks and then take Zinc supplements for 2 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Zinc GluconateDuring the study period, all subjects were required to avoid a diet high in zinc in order to avoid interference with dietary zinc intake and reduce bias in the weeks 1-2. In the weeks 3-4, all subjects were started to receive zinc supplementation at the normal adult dose (zinc tablets: 1 tablet (10mg Zinc) once daily after meals), while maintaining the avoidance of high-zinc foods. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults aged 20-30 years from the general community were recruited to participate in the study voluntarily without underlying diseases.
Key exclusion criteria (1 listed)
- Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation; Those who have taken hormones within 3 months; Have taken any drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and have had probiotic intervention within 1 month; smokers and drinkers; Uncontrollable mental disorders (including hospitalization history of mental illness); (6) Currently attending a weight loss or weight management course; prescribed diet for specific or other reasons (e.g. celiac disease); pregnant or lactating women; Patients with cardiac and renal insufficiency; Patients with other underlying diseases; Long-term constipation.
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 GluconateEach participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4. | Dietary supplement | Experimental Group |
Primary outcome
16S rDNA sequencing
Time frame: 14days，28 days
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.
metabolomic analysis of serum and feces
Time frame: 14days，28 days
To determine the alteration of gut microbiota after Zn supplementary.
The blood levels of Zn2+ in each study phase
Time frame: 14days，28 days
The blood levels of Zn2+ would be detected on day 14 and day 28.
Number of participantswith abnormal laboratory tests results
Time frame: 14days，28 days
If there are abnormal situations during the experiment that may pose significant risks to the health or safety of the participants, the research team may need to terminate the experiment to ensure participant safety. Only
The fecal Zn2+ concentration in each study phase
Time frame: 14days，28 days
The fecal Zn2+ concentration would be detected on day 14 and day 28.
21 secondary outcomes
Total bilirubin concentration after 14days oral Zn.
Time frame: 14days，28 days
Direct bilirubin concentration after 14days oral Zn.
Time frame: 14days，28 days
Indirect bilirubin concentration after 14days oral Zn.
Time frame: 14days，28 days
uric acid concentration after 14days oral Zn.
Time frame: 14days，28 days
total triglyceride concentration after 14days oral Zn.
Time frame: 14days，28 days
total protein concentration after 14days oral Zn.
Time frame: 14days，28 days
aspartate transaminase concentration after 14days oral Zn.
Time frame: 14days，28 days
alanine transaminase concentration after 14days oral Zn.
Time frame: 14days，28 days
albumin concentration after 14days oral Zn.
Time frame: 14days，28 days
total cholesterol concentration after 14days oral Zn.
Time frame: 14days，28 days
Urea concentration after 14days oral Zn.
Time frame: 14days，28 days
HDL-C concentration after 14days oral Zn.
Time frame: 14days，28 days
LDL-C concentration after 14days oral Zn.
Time frame: 14days，28 days
Red blood cells analysis after 14days oral Zn.
Time frame: 14days，28 days
Plateltes analysis after 14days oral Zn.
Time frame: 14days，28 days
Neutrophil cells analysis after 14days oral Zn.
Time frame: 14days，28 days
Eosinophil cells analysis after 14days oral Zn.
Time frame: 14days，28 days
Basophil cells analysis after 14days oral Zn.
Time frame: 14days，28 days
Lymphocyte cells analysis after 14days oral Zn.
Time frame: 14days，28 days
Monocyte cells analysis after 14days oral Zn.
Time frame: 14days，28 days
White blood cells analysis after 14days oral Zn.
Time frame: 14days，28 days
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 9 Oct 2024.
- Background: PubMed 27317042Ackland ML, Michalczyk AA. Zinc and infant nutrition. Arch Biochem Biophys. 2016 Dec 1;611:51-57. doi: 10.1016/j.abb.2016.06.011. Epub 2016 Jun 15.
- Derived from this study: PubMed 39610253Li D, Wan M, Xue L, Zhang Z, Qiu Y, Mei F, Tang N, Yu C, Yu Y, Chen T, Ding X, Yang Q, Liu Q, Gu P, Jia W, Chen Y, Chen P. Zinc promotes microbial p-coumaric acid production that protects against cholestatic liver injury. Cell Host Microbe. 2024 Dec 11;32(12):2195-2211.e9. doi: 10.1016/j.chom.2024.11.002. Epub 2024 Nov 27.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Since some data may involve subject's privacy #we have no plans to share data so far# and some data may be shared later depending on the subjects's wishes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gluconate in people with Healthy, run by The Seventh Affiliated Hospital, Southern Medical University at 1 site in China.
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 1 inclusion and 1 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 9 Oct 2024. 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 China. 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?
16S rDNA sequencing (time frame: 14days，28 days). The study lists 5 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 NCT05597137, which also lists 2 linked publications.
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 9 Oct 2024.