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

NCT05597150 | Completed DMC

• 1 other identifier: (2022)--0009
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy State

Keywords

magnesium, gut microbiota, healthy adult

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (22)

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

  21days, 42 days

• Total bilirubin concentration after 21days oral Mg.

  21days, 42 days

• Direct bilirubin concentration after 21days oral Mg.

  21days, 42 days

• Indirect bilirubin concentration after 21days oral Mg.

  21days, 42 days

• uric acid concentration after 21days oral Mg.

  21days, 42 days

Study Arms (1)

Experimental Group

EXPERIMENTAL

Dietary Supplement: Magnesium Citrate

Interventions

Magnesium Citrate DIETARY_SUPPLEMENT

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

Experimental Group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Seventh Affiliated Hospital, Southern Medical University: lead

Study Sites (1)

Southern Medical Unversity,the seventh affiliated hospita

Foshan, Guangdong, 528000, China

Location

Related Publications (1)

• Li D, Chen Y, Wan M, Mei F, Wang F, Gu P, Zhang X, Wei R, Zeng Y, Zheng H, Chen B, Xiong Q, Xue T, Guan T, Guo J, Tian Y, Zeng LY, Liu Z, Yuan H, Yang L, Liu H, Dai L, Yu Y, Qiu Y, Wu P, Win S, Than TA, Wei R, Schnabl B, Kaplowitz N, Jiang Y, Ma Q, Chen P. Oral magnesium prevents acetaminophen-induced acute liver injury by modulating microbial metabolism. Cell Host Microbe. 2024 Jan 10;32(1):48-62.e9. doi: 10.1016/j.chom.2023.11.006. Epub 2023 Dec 5.

  PMID: 38056458 DERIVED

MeSH Terms

Interventions

magnesium citrate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: October 15, 2022
• Primary Completion: January 30, 2023
• Study Completion: March 1, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)