The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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: 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group
|
Dietary Supplement: Magnesium Citrate
Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
|
Outcome Measures
Primary Outcome Measures
- 16S rDNA sequencing [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 [42 days]
To determine the alteration of gut microbiota and their metabolites after Mg supplementary.
Secondary Outcome Measures
- The serum levels of Mg2+ in each study phase. [42 days]
The serum levels of Mg2+ would be detected on day 0, day 21 and day 42.
- blood routine examination and lood biochemical examination [42 days]
Evaluation on the physiological situation of the subjects.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged 20-30 years in the general community
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Without gender or ethnic requirements, who did not participate in other trials at the same time, volunteered to participate in this study
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No underlying diseases.
Exclusion Criteria:
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(1) Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation;
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(2) Those who have taken hormones within 3 months;
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(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;
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(4) smokers and drinkers;
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(5) Uncontrollable mental disorders (including hospitalization history of mental illness);
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(6) Currently attending a weight loss or weight management course;
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(7) prescribed diet for specific or other reasons (e.g. celiac disease);
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(8) pregnant or lactating women;
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(9) Patients with cardiac and renal insufficiency;
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(10) Long-term constipation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Medical Unversity,the seventh affiliated hospita | Foshan | Guangdong | China | 528000 |
Sponsors and Collaborators
- The Seventh Affiliated Hospital, Southern Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- (2022)--0009