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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy State
• Intervention / Treatment: Dietary supplement: Magnesium Citrate

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: 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
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Southern Medical Unversity,the seventh affiliated hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
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
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
The fecal Mg2+ concentration in each study phase.	The fecal Mg2+ concentration would be detected on day 21 and day 42.	21days, 42 days

Collaborators and Investigators

• Sponsor: The Seventh Affiliated Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: magnesium, gut microbiota, healthy adult
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Magnesium citrate
• Other Study ID Numbers: (2022)--0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No