Healthy StateNCT05597150
The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults
A study testing Magnesium Citrate in people with Healthy State, 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-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 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 State
- What is being tested?
- Magnesium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2022to 1 Mar 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 in the general community
- Without gender or ethnic requirements, who did not participate in other trials at the same time, volunteered to participate in this study
- No underlying diseases.
Who cannot join
- (1) Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation;
- (2) Those who have taken hormones within 3 months;
- (3) Those who have taken drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and those who have taken probiotics within 1 month;
- (4) smokers and drinkers;
- (5) Uncontrollable mental disorders (including hospitalization history of mental illness);
- (6) Currently attending a weight loss or weight management course;
Show all 10Show fewer
- (7) prescribed diet for specific or other reasons (e.g. celiac disease);
- (8) pregnant or lactating women;
- (9) Patients with cardiac and renal insufficiency;
- (10) Long-term constipation.
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical Unversity,the seventh affiliated hospita
Foshan, Guangdong, 528000
About this study
Official title: To Explore the Regulatory Effect of Magnesium 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-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
Read the detailed description
Investigational drug# Oral magnesium Study title# To explore the regulatory effect of magnesium on intestinal flora in healthy adults # A Single-center, Prospective, Self-controlled trial.
Principal Investigator# Professor Yu Chen, Department of Gastroenterology, The Seventh Affiliated Hospital, Southern Medical University.
Professor Peng Chen, Department of Pathophysiology, School of Basic Medical Sciences, Southern Medical University.
Study subjects# Healthy adult, Age 20-30 years Study phase# Investigator Initiated Trial(IIT) Study objectives# The objective of the study is to explore the regulatory effect of magnesium on intestinal flora in healthy adults Study design# A Single-center, Prospective, Self-controlled trial. Medication method# Subjects should avoid high magnesium diet for 1-3 weeks, and take magnesium supplement (food grade magnesium citrate: three capsules a day, after meals, 400mg magnesium) in 4-6 weeks. Peripheral blood and stool samples were collected from 60 subjects on day 0, day 21, and day 42 of the study period for routine blood tests, blood biochemical tests, and 16s rDNA sequencing analysis of gut microbiota.
Course#42days Sample size#60.
- Conditions
- Healthy State
- Being tested
- Magnesium Citrate
- Keywords
- magnesium, gut microbiota, healthy adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium CitrateDietary supplement
Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Dietary Supplement: Magnesium Citrate |
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 magnesium supplementation.
Measured: 21days, 42 days
Metabolomic analysis of serum and feces
To determine the alteration of gut microbiota and their metabolites after Mg supplementary.
Measured: 21days, 42 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: 21days, 42 days
Secondary outcomes (22)
The plasma levels of Mg2+ in each study phase.
The plasma levels of Mg2+ would be detected on day 21 and day 42.
Measured: 21days, 42 days
Total bilirubin concentration after 21days oral Mg.
change from 21days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
Direct bilirubin concentration after 21days oral Mg.
change from 21days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
Indirect bilirubin concentration after 21days oral Mg.
change from 21days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
uric acid concentration after 21days oral Mg.
change from 21days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
total triglyceride concentration after 21days oral Mg.
change from 21days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
total protein concentration after 21days oral Mg.
change from 21days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
aspartate transaminase concentration after 21days oral Mg.
change from 21days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
alanine transaminase concentration after 21days oral Mg.
change from 21days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
albumin concentration after 21days oral Mg.
change from 21days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
total cholesterol concentration after 21days oral Mg.
change from 21days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
Urea concentration after 21days oral Mg.
change from 21days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
HDL-C concentration after 21days oral Mg.
change from 21days in HDL-C(high density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
LDL-C concentration after 21days oral Mg.
change from 21days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic biochemical analyzer.
Measured: 21days, 42 days
Red blood cells analysis after 21days oral Mg.
change from 21days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Plateltes analysis after 21days oral Mg.
change from 21days in Plateltes cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Neutrophil cells analysis
change from 21days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Eosinophil cells analysis after 21days oral Mg.
change from 21days in Eosinophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Basophil cells analysis after 21days oral Mg.
change from 21days in Basophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Lymphocyte cells analysis after 21days oral Mg.
change from 21days in Lymphocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
Monocyte cells analysis after 21days oral Mg.
change from 21days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Measured: 21days, 42 days
The fecal Mg2+ concentration in each study phase.
The fecal Mg2+ concentration would be detected on day 21 and day 42.
Measured: 21days, 42 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 start15 Oct 2022
- Primary completion30 Jan 2023
- Study completion1 Mar 2023
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 Healthy StateStudies 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
- 41 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
- NCT05597150
- Sponsor's protocol ID
- (2022)--0009
- 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
Li D, Chen Y, Wan M, Mei F, Wang F, Gu P, Zhang X, Wei R, Zeng Y, Zheng H, Chen B, Xiong Q, Xue T, Guan T, Guo J, Tian Y, Zeng LY, Liu Z, Yuan H, Yang L, Liu H, Dai L, Yu Y, Qiu Y, Wu P, Win S, Than TA, Wei R, Schnabl B, Kaplowitz N, Jiang Y, Ma Q, Chen P. Oral magnesium prevents acetaminophen-induced acute liver injury by modulating microbial metabolism. Cell Host Microbe. 2024 Jan 10;32(1):48-62.e9. doi: 10.1016/j.chom.2023.11.006. Epub 2023 Dec 5.
PubMed 38056458
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 Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
- ClinicalTrials.gov ID
- NCT05597150
- Acronym / sponsor ID
- (2022)--0009
- Conditions
- Healthy State
- Keywords
- magnesium, gut microbiota, healthy adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The Seventh Affiliated Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Mar 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-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
Detailed description
Investigational drug# Oral magnesium Study title# To explore the regulatory effect of magnesium on intestinal flora in healthy adults # A Single-center, Prospective, Self-controlled trial.
Principal Investigator# Professor Yu Chen, Department of Gastroenterology, The Seventh Affiliated Hospital, Southern Medical University.
Professor Peng Chen, Department of Pathophysiology, School of Basic Medical Sciences, Southern Medical University.
Study subjects# Healthy adult, Age 20-30 years Study phase# Investigator Initiated Trial(IIT) Study objectives# The objective of the study is to explore the regulatory effect of magnesium on intestinal flora in healthy adults Study design# A Single-center, Prospective, Self-controlled trial. Medication method# Subjects should avoid high magnesium diet for 1-3 weeks, and take magnesium supplement (food grade magnesium citrate: three capsules a day, after meals, 400mg magnesium) in 4-6 weeks. Peripheral blood and stool samples were collected from 60 subjects on day 0, day 21, and day 42 of the study period for routine blood tests, blood biochemical tests, and 16s rDNA sequencing analysis of gut microbiota.
Course#42days Sample size#60.
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: Magnesium Citrate |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 20-30 years in the general community
- Without gender or ethnic requirements, who did not participate in other trials at the same time, volunteered to participate in this study
- No underlying diseases.
Key exclusion criteria (10 listed)
- (1) Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation;
- (2) Those who have taken hormones within 3 months;
- (3) Those who have taken drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and those who have taken probiotics within 1 month;
- (4) smokers and drinkers;
- (5) Uncontrollable mental disorders (including hospitalization history of mental illness);
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 |
|---|---|---|
| Magnesium CitrateEach participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks. | Dietary supplement | Experimental Group |
Primary outcome
16S rDNA sequencing
Time frame: 21days, 42 days
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after magnesium supplementation.
Metabolomic analysis of serum and feces
Time frame: 21days, 42 days
To determine the alteration of gut microbiota and their metabolites after Mg supplementary.
Number of participantswith abnormal laboratory tests results
Time frame: 21days, 42 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
22 secondary outcomes
The plasma levels of Mg2+ in each study phase.
Time frame: 21days, 42 days
Total bilirubin concentration after 21days oral Mg.
Time frame: 21days, 42 days
Direct bilirubin concentration after 21days oral Mg.
Time frame: 21days, 42 days
Indirect bilirubin concentration after 21days oral Mg.
Time frame: 21days, 42 days
uric acid concentration after 21days oral Mg.
Time frame: 21days, 42 days
total triglyceride concentration after 21days oral Mg.
Time frame: 21days, 42 days
total protein concentration after 21days oral Mg.
Time frame: 21days, 42 days
aspartate transaminase concentration after 21days oral Mg.
Time frame: 21days, 42 days
alanine transaminase concentration after 21days oral Mg.
Time frame: 21days, 42 days
albumin concentration after 21days oral Mg.
Time frame: 21days, 42 days
total cholesterol concentration after 21days oral Mg.
Time frame: 21days, 42 days
Urea concentration after 21days oral Mg.
Time frame: 21days, 42 days
HDL-C concentration after 21days oral Mg.
Time frame: 21days, 42 days
LDL-C concentration after 21days oral Mg.
Time frame: 21days, 42 days
Red blood cells analysis after 21days oral Mg.
Time frame: 21days, 42 days
Plateltes analysis after 21days oral Mg.
Time frame: 21days, 42 days
Neutrophil cells analysis
Time frame: 21days, 42 days
Eosinophil cells analysis after 21days oral Mg.
Time frame: 21days, 42 days
Basophil cells analysis after 21days oral Mg.
Time frame: 21days, 42 days
Lymphocyte cells analysis after 21days oral Mg.
Time frame: 21days, 42 days
Monocyte cells analysis after 21days oral Mg.
Time frame: 21days, 42 days
The fecal Mg2+ concentration in each study phase.
Time frame: 21days, 42 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.
- Derived from this study: PubMed 38056458Li D, Chen Y, Wan M, Mei F, Wang F, Gu P, Zhang X, Wei R, Zeng Y, Zheng H, Chen B, Xiong Q, Xue T, Guan T, Guo J, Tian Y, Zeng LY, Liu Z, Yuan H, Yang L, Liu H, Dai L, Yu Y, Qiu Y, Wu P, Win S, Than TA, Wei R, Schnabl B, Kaplowitz N, Jiang Y, Ma Q, Chen P. Oral magnesium prevents acetaminophen-induced acute liver injury by modulating microbial metabolism. Cell Host Microbe. 2024 Jan 10;32(1):48-62.e9. doi: 10.1016/j.chom.2023.11.006. Epub 2023 Dec 5.
- 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.
Related trials for Healthy State
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers
Healthy Female Adult Volunteers
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
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 Magnesium Citrate in people with Healthy State, 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 3 inclusion and 10 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: 21days, 42 days). The study lists 3 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 NCT05597150, 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 9 Oct 2024.