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Changes in Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women

Not Applicable
Completed
Conditions
Healthy
Interventions
Behavioral: Physical activity
Registration Number
NCT05927675
Lead Sponsor
Seoul National University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
27
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Exercise interventionPhysical activity-
Primary Outcome Measures
NameTimeMethod
Change in Systolic blood pressure (SBP) between baseline and 3rd monthbaseline ~ 3 month

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

Change in Systolic blood pressure (SBP) between 3rd month and 6th month3 ~ 6 month

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

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

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

Changes in diastolic blood pressure (DBP) between 3rd month and 6th month3 ~ 6 month

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

Changes in hemoglobin A1c (HbA1c) between baseline and 3rd monthbaseline ~ 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 month3 ~ 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 monthbaseline ~ 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 monthbaseline ~ 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 month3 ~ 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 monthbaseline ~ 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 month3 ~ 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 monthbaseline ~ 3 month

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

Changes in total cholesterol between 3rd month and 6th month3 ~ 6 month

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

Changes in Microbiome between 3rd month and 6th month3 ~ 6 month

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

Changes in Metabolome between baseline and 3rd monthbaseline ~ 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 month3 ~ 6 month

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Seoul National University

🇰🇷

Seoul, Korea, Republic of

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