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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
41
Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
Southern Medical Unversity,the seventh affiliated hospita
Foshan, Guangdong, China
16S rDNA sequencing
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after magnesium supplementation.
Time frame: 21days, 42 days
Metabolomic analysis of serum and feces
To determine the alteration of gut microbiota and their metabolites after Mg supplementary.
Time frame: 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
Time frame: 21days, 42 days
The plasma levels of Mg2+ in each study phase.
The plasma levels of Mg2+ would be detected on day 21 and day 42.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21days, 42 days
albumin concentration after 21days oral Mg.
change from 21days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.
Time frame: 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.
Time frame: 21days, 42 days
Urea concentration after 21days oral Mg.
change from 21days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21days, 42 days
Neutrophil cells analysis
change from 21days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21days, 42 days
The fecal Mg2+ concentration in each study phase.
The fecal Mg2+ concentration would be detected on day 21 and day 42.
Time frame: 21days, 42 days