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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Citrate | Dietary Supplement | Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 16S rDNA sequencing | 16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after magnesium supplementation. | 21days, 42 days |
| Metabolomic analysis of serum and feces | To determine the alteration of gut microbiota and their metabolites after Mg supplementary. | 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 | 21days, 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma levels of Mg2+ in each study phase. | The plasma levels of Mg2+ would be detected on day 21 and day 42. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical Unversity,the seventh affiliated hospita | Foshan | Guangdong | 528000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38056458 | Derived | 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. |
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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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| ID | Term |
|---|---|
| C110422 | magnesium citrate |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 21days, 42 days |
| albumin concentration after 21days oral Mg. | change from 21days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer. | 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. | 21days, 42 days |
| Urea concentration after 21days oral Mg. | change from 21days in urea and analyzed by the AU5800 fully automatic biochemical analyzer. | 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. | 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. | 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. | 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. | 21days, 42 days |
| Neutrophil cells analysis | change from 21days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser. | 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. | 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. | 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. | 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. | 21days, 42 days |
| The fecal Mg2+ concentration in each study phase. | The fecal Mg2+ concentration would be detected on day 21 and day 42. | 21days, 42 days |