Clinical trial NCT05597150: The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults
Official title: To Explore the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy State
Keywords: magnesium, gut microbiota, healthy adult
Lead sponsor: The Seventh Affiliated Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 16S rDNA sequencing
timeFrame: 21days, 42 days
measure: Metabolomic analysis of serum and feces
timeFrame: 21days, 42 days
measure: Number of participantswith abnormal laboratory tests results
timeFrame: 21days, 42 days
Secondary outcomes:
measure: The plasma levels of Mg2+ in each study phase.
timeFrame: 21days, 42 days
measure: Total bilirubin concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Direct bilirubin concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Indirect bilirubin concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: uric acid concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: total triglyceride concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: total protein concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: aspartate transaminase concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: alanine transaminase concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: albumin concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: total cholesterol concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Urea concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: HDL-C concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: LDL-C concentration after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Red blood cells analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Plateltes analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Neutrophil cells analysis
timeFrame: 21days, 42 days
measure: Eosinophil cells analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Basophil cells analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Lymphocyte cells analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: Monocyte cells analysis after 21days oral Mg.
timeFrame: 21days, 42 days
measure: The fecal Mg2+ concentration in each study phase.
timeFrame: 21days, 42 days
Other outcomes:
Locations:
city: Foshan
country: China
facility: Southern Medical Unversity,the seventh affiliated hospita
state: Guangdong
Study officials:
References: