Clinical trial NCT05927675: Changes in Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women
Official title: Dynamic Profiling of Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Microbiome
Metabolite
Physical activity
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 27
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Systolic blood pressure (SBP) between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Change in Systolic blood pressure (SBP) between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in diastolic blood pressure (DBP) between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in diastolic blood pressure (DBP) between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in hemoglobin A1c (HbA1c) between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in total cholesterol between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in total cholesterol between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in high-density lipoprotein cholesterol (HDL-C) between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in high-density lipoprotein cholesterol (HDL-C) between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in low-density lipoprotein cholesterol (LDL-C) betweenbaseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in low-density lipoprotein cholesterol (LDL-C) between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in Microbiome between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in Microbiome between 3rd month and 6th month
timeFrame: 3 ~ 6 month
measure: Changes in Metabolome between baseline and 3rd month
timeFrame: baseline ~ 3 month
measure: Changes in Metabolome between 3rd month and 6th month
timeFrame: 3 ~ 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Seoul National University
name: Ji-Yeob Choi
role: PRINCIPAL_INVESTIGATOR
References: