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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise intervention

Behavioral: Physical activity; The exercise intervention program consisted of two distinct periods. During period 1, subjects participated in a moderate to vigorous intensity exercise program for 40 minutes a day, 4 days a week. The exercise program was conducted in Tabata format targeting 70% of the maximum heart rate. Recovery was then induced for 1 minute and 30 seconds, allowing the heart rate to return to resting levels. The exercise routine primarily consisted of full-body exercises, functional training, and power exercises. During period 2, a low-intensity static exercise program was implemented. Similar to period 1, the subjects exercised for 40 minutes a day, 4 days a week. The exercise program included static exercises. The maximum heart rate was maintained below 50%. The detailed exercise program consisted of stretching movements and balance movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic blood pressure (SBP) between baseline and 3rd month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	baseline ~ 3 month
Change in Systolic blood pressure (SBP) between 3rd month and 6th month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	3 ~ 6 month
Changes in diastolic blood pressure (DBP) between baseline and 3rd month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	baseline ~ 3 month
Changes in diastolic blood pressure (DBP) between 3rd month and 6th month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	3 ~ 6 month
Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month	The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)	baseline ~ 3 month
Changes in hemoglobin A1c (HbA1c) between 3rd month and 6th month	The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)	3 ~ 6 month
Changes in total cholesterol between baseline and 3rd month	total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	baseline ~ 3 month
Changes in total cholesterol between 3rd month and 6th month	total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	3 ~ 6 month
Changes in high-density lipoprotein cholesterol (HDL-C) between baseline and 3rd month	high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	baseline ~ 3 month
Changes in high-density lipoprotein cholesterol (HDL-C) between 3rd month and 6th month	high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	3 ~ 6 month
Changes in low-density lipoprotein cholesterol (LDL-C) betweenbaseline and 3rd month	low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	baseline ~ 3 month
Changes in low-density lipoprotein cholesterol (LDL-C) between 3rd month and 6th month	low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	3 ~ 6 month
Changes in Microbiome between baseline and 3rd month	The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.	baseline ~ 3 month
Changes in Microbiome between 3rd month and 6th month	The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.	3 ~ 6 month
Changes in Metabolome between baseline and 3rd month	Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.	baseline ~ 3 month
Changes in Metabolome between 3rd month and 6th month	Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.	3 ~ 6 month

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Principal Investigator: Ji-Yeob Choi, Seoul National University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Physical activity; Metabolite
• Other Study ID Numbers: PA-1812-129-997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No