To Explore the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 16S rDNA sequencing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •(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.
结局指标
主要结局
16S rDNA sequencing
时间窗: 21days, 42 days
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after magnesium supplementation.
Metabolomic analysis of serum and feces
时间窗: 21days, 42 days
To determine the alteration of gut microbiota and their metabolites after Mg supplementary.
Number of participantswith abnormal laboratory tests results
时间窗: 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
次要结局
- Total bilirubin concentration after 21days oral Mg.(21days, 42 days)
- The plasma levels of Mg2+ in each study phase.(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)
- total triglyceride concentration after 21days oral Mg.(21days, 42 days)
- total protein concentration after 21days oral Mg.(21days, 42 days)
- aspartate transaminase concentration after 21days oral Mg.(21days, 42 days)
- alanine transaminase concentration after 21days oral Mg.(21days, 42 days)
- albumin concentration after 21days oral Mg.(21days, 42 days)
- total cholesterol concentration after 21days oral Mg.(21days, 42 days)
- Urea concentration after 21days oral Mg.(21days, 42 days)
- HDL-C concentration after 21days oral Mg.(21days, 42 days)
- LDL-C concentration after 21days oral Mg.(21days, 42 days)
- Red blood cells analysis after 21days oral Mg.(21days, 42 days)
- Plateltes analysis after 21days oral Mg.(21days, 42 days)
- Neutrophil cells analysis(21days, 42 days)
- Eosinophil cells analysis after 21days oral Mg.(21days, 42 days)
- Basophil cells analysis after 21days oral Mg.(21days, 42 days)
- Lymphocyte cells analysis after 21days oral Mg.(21days, 42 days)
- Monocyte cells analysis after 21days oral Mg.(21days, 42 days)
- The fecal Mg2+ concentration in each study phase.(21days, 42 days)
研究者
Yu Chen
chief physician
The Seventh Affiliated Hospital, Southern Medical University