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临床试验/NCT05927675
NCT05927675已完成不适用

Dynamic Profiling of Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women

Seoul National University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Change in Systolic blood pressure (SBP) between baseline and 3rd month

研究概览

简要总结

This study aimed to examine the effect of physical activity (PA) on health through changes in multi-omics biomarkers during 6 months of exercise intervention.

详细描述

This study aimed to examine the effect of physical activity (PA) on health through changes in multi-omics biomarkers during 6 months of exercise intervention. Twenty-seven healthy middle-aged women were recruited and 14 subjects completed the exercise intervention. A total of three blood and stool samples were collected at 3-month intervals. The amount of PA was measured with an accelerometer. Clinical variables were used, including blood pressure, grip strength, flexibility, and blood glucose levels and lipid markers obtained from laboratory tests. The concentration of blood metabolites was measured by targeted metabolomics. Fecal microbiome data were obtained by 16S rRNA gene amplicon sequencing. During the second half period (period 2), Coronavirus disease 2019 (COVID-19) occurred and spread out in Korea, and PA decreased compared with the first half period (period 1). Blood pressure, hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) decreased in period 1 and tended to increase again during period 2. Forty metabolites were changed significantly during period 1, and investigators found that 6 of them were correlated with changes in blood pressure, HbA1c, and LDL-C via network analysis. Our results may suggest the relationship between changes in biomarkers at multi-omics levels during exercise and a message that reduced PA due to COVID-19 can adversely affect health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •age 40 - 59 (middled aged women)
  • •Those who have no difficulties in daily living
  • •Those who engage in sedentary activities most of the day
  • •Willing to commit throughout the study

排除标准

  • •Antibiotics medication in the last month.
  • •Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke

研究组 & 干预措施

Exercise intervention

Experimental

干预措施: Physical activity (Behavioral)

结局指标

主要结局

Change in Systolic blood pressure (SBP) between baseline and 3rd month

时间窗: baseline ~ 3 month

blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

Change in Systolic blood pressure (SBP) between 3rd month and 6th month

时间窗: 3 ~ 6 month

blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

Changes in diastolic blood pressure (DBP) between baseline and 3rd month

时间窗: baseline ~ 3 month

blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

Changes in diastolic blood pressure (DBP) between 3rd month and 6th month

时间窗: 3 ~ 6 month

blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month

时间窗: baseline ~ 3 month

The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

Changes in hemoglobin A1c (HbA1c) between 3rd month and 6th month

时间窗: 3 ~ 6 month

The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

Changes in total cholesterol between baseline and 3rd month

时间窗: baseline ~ 3 month

total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in high-density lipoprotein cholesterol (HDL-C) between baseline and 3rd month

时间窗: baseline ~ 3 month

high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in high-density lipoprotein cholesterol (HDL-C) between 3rd month and 6th month

时间窗: 3 ~ 6 month

high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in low-density lipoprotein cholesterol (LDL-C) betweenbaseline and 3rd month

时间窗: baseline ~ 3 month

low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in low-density lipoprotein cholesterol (LDL-C) between 3rd month and 6th month

时间窗: 3 ~ 6 month

low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in Microbiome between baseline and 3rd month

时间窗: baseline ~ 3 month

The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

Changes in total cholesterol between 3rd month and 6th month

时间窗: 3 ~ 6 month

total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

Changes in Microbiome between 3rd month and 6th month

时间窗: 3 ~ 6 month

The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

Changes in Metabolome between baseline and 3rd month

时间窗: baseline ~ 3 month

Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

Changes in Metabolome between 3rd month and 6th month

时间窗: 3 ~ 6 month

Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JiYeob Choi

Professor

Seoul National University

研究点 (1)

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