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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927675
• Other study ID #: PA-1812-129-997
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: February 8, 2022

Study information

• Verified date: June 2023
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic blood pressure (SBP) between baseline and 3rd month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	baseline ~ 3 month
Primary	Change in Systolic blood pressure (SBP) between 3rd month and 6th month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	3 ~ 6 month
Primary	Changes in diastolic blood pressure (DBP) between baseline and 3rd month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	baseline ~ 3 month
Primary	Changes in diastolic blood pressure (DBP) between 3rd month and 6th month	blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)	3 ~ 6 month
Primary	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
Primary	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
Primary	Changes in total cholesterol between baseline and 3rd month	total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)	baseline ~ 3 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in Microbiome between baseline and 3rd month	The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.	baseline ~ 3 month
Primary	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
Primary	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
Primary	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