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

NCT ID: NCT05927675

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2022-02-08

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise intervention

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University

OTHER

Sponsor Role: lead

Responsible Party

JiYeob Choi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji-Yeob Choi

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

Seoul National University

Seoul, , South Korea

Countries

South Korea

References

Park J, Kim J, Kang J, Choi J, Kim JE, Min KJ, Choi SW, Cho JY, Lee M, Choi JY. A 6-month exercise intervention clinical trial in women: effects of physical activity on multi-omics biomarkers and health during the first wave of COVID-19 in Korea. BMC Sports Sci Med Rehabil. 2024 Jan 29;16(1):30. doi: 10.1186/s13102-024-00824-6.

Reference Type: DERIVED

PMID: 38287431 (View on PubMed)

Other Identifiers

PA-1812-129-997

Identifier Type: -

Identifier Source: org_study_id