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

Healthy State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597150
• Other study ID #: (2022)--0009
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: The Seventh Affiliated Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 1, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy State

Intervention

Dietary Supplement:
• Magnesium Citrate
Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.

Locations

Country	Name	City	State
China	Southern Medical Unversity,the seventh affiliated hospita	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Seventh Affiliated Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Metabolomic analysis of serum and feces	To determine the alteration of gut microbiota and their metabolites after Mg supplementary.	21days, 42 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	albumin concentration after 21days oral Mg.	change from 21days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.	21days, 42 days
Secondary	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
Secondary	Urea concentration after 21days oral Mg.	change from 21days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.	21days, 42 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Neutrophil cells analysis	change from 21days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	21days, 42 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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