Clinical Trials Directory

Trials / Completed

CompletedNCT05927675

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Seoul National University · Academic / Other
Sex
Female
Age
40 Years – 59 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALPhysical activityThe 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.

Timeline

Start date
2019-05-10
Primary completion
2022-02-08
Completion
2022-02-08
First posted
2023-07-03
Last updated
2023-07-03

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05927675. Inclusion in this directory is not an endorsement.