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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-03-01

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.

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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: 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.

Conditions

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Healthy State

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental Group

Group Type EXPERIMENTAL

Magnesium Citrate

Intervention Type DIETARY_SUPPLEMENT

Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.

Interventions

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Magnesium Citrate

Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes