Skip to main content
OpenTrials
Completed

NCT Number: NCT05597150

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Medical Unversity,the seventh affiliated hospita

Foshan, Guangdong, 528000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium citrate

Dietary Supplement

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

Primary outcomes

  1. 16S rDNA sequencing

    Time frame: 21days, 42 days

    16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after magnesium supplementation.

  2. Metabolomic analysis of serum and feces

    Time frame: 21days, 42 days

    To determine the alteration of gut microbiota and their metabolites after Mg supplementary.

  3. Number of participantswith abnormal laboratory tests results

    Time frame: 21days, 42 days

    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

Secondary outcomes

  1. The plasma levels of Mg2+ in each study phase.

    Time frame: 21days, 42 days

    The plasma levels of Mg2+ would be detected on day 21 and day 42.

  2. Total bilirubin concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  3. Direct bilirubin concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  4. Indirect bilirubin concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  5. uric acid concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.

  6. total triglyceride concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.

  7. total protein concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.

  8. aspartate transaminase concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.

  9. alanine transaminase concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.

  10. albumin concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.

  11. total cholesterol concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.

  12. Urea concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.

  13. HDL-C concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in HDL-C(high density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic biochemical analyzer.

  14. LDL-C concentration after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic biochemical analyzer.

  15. Red blood cells analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  16. Plateltes analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Plateltes cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  17. Neutrophil cells analysis

    Time frame: 21days, 42 days

    change from 21days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  18. Eosinophil cells analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Eosinophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  19. Basophil cells analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Basophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  20. Lymphocyte cells analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Lymphocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  21. Monocyte cells analysis after 21days oral Mg.

    Time frame: 21days, 42 days

    change from 21days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  22. The fecal Mg2+ concentration in each study phase.

    Time frame: 21days, 42 days

    The fecal Mg2+ concentration would be detected on day 21 and day 42.

Sponsors and collaborators

Lead sponsor

The Seventh Affiliated Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.