The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 1 capsule, 400mg/ capsule, three times a day, after meals) 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.

Official Title
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To Explore the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial

Conditions
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Healthy State

Intervention / Treatment
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* Dietary Supplement: Magnesium Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: (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; (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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Dietary Supplement: Magnesium Citrate<br>* Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The serum levels of Mg2+ in each study phase. | The serum 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium, gut microbiota, healthy adult