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Completed

NCT Number: NCT05927675

Changes in 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.

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Key information

Conditions

Healthy Behavior Motor Activity

Age range

40 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

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.

Primary outcomes

  1. Change in Systolic blood pressure (SBP) between baseline and 3rd month

    Time frame: baseline ~ 3 month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

  2. Change in Systolic blood pressure (SBP) between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

  3. Changes in diastolic blood pressure (DBP) between baseline and 3rd month

    Time frame: baseline ~ 3 month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

  4. Changes in diastolic blood pressure (DBP) between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)

  5. Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month

    Time frame: baseline ~ 3 month

    The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

  6. Changes in hemoglobin A1c (HbA1c) between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    The concentrations of hemoglobin A1c (HbA1c) (mg/dL) (HLC-723G11 analyzer, TOSOH kabushiki kaisha, HPLC)

  7. Changes in total cholesterol between baseline and 3rd month

    Time frame: baseline ~ 3 month

    total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  8. Changes in total cholesterol between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    total cholesterol (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  9. Changes in high-density lipoprotein cholesterol (HDL-C) between baseline and 3rd month

    Time frame: baseline ~ 3 month

    high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  10. Changes in high-density lipoprotein cholesterol (HDL-C) between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    high-density lipoprotein cholesterol (HDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  11. Changes in low-density lipoprotein cholesterol (LDL-C) betweenbaseline and 3rd month

    Time frame: baseline ~ 3 month

    low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  12. Changes in low-density lipoprotein cholesterol (LDL-C) between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    low-density lipoprotein cholesterol (LDL-C) (mg/dL) (Cobas C701/702 autochemistry analyzer, Roche, enzyme method)

  13. Changes in Microbiome between baseline and 3rd month

    Time frame: baseline ~ 3 month

    The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

  14. Changes in Microbiome between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    The composition of the gut microbiome obtained by 16S rRNA gene amplicon sequencing.

  15. Changes in Metabolome between baseline and 3rd month

    Time frame: baseline ~ 3 month

    Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

  16. Changes in Metabolome between 3rd month and 6th month

    Time frame: 3 ~ 6 month

    Plasma metabolite concentrations were measured by using the AbsoluteIDQ p 180 kit and the Bile acids kit.

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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