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HealthyNCT05927675

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

A study testing Physical activity in people with Healthy, run by Seoul National University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 59 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSouth Korea
Study dates
10 May 2019to 8 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Dynamic Profiling of 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.

Read the 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
Being tested
Physical activity
Keywords
Microbiome, Metabolite, Physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activityBehavioural

    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.

Study groups in NCT05927675
Study groupRoleWhat they receive
Exercise interventionExperimentalNot described
Receives: Behavioral: Physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: baseline ~ 3 month

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

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

    Measured: 3 ~ 6 month

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

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

    Measured: baseline ~ 3 month

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

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

    Measured: 3 ~ 6 month

  5. 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)

    Measured: baseline ~ 3 month

  6. 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)

    Measured: 3 ~ 6 month

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

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

    Measured: baseline ~ 3 month

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

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

    Measured: 3 ~ 6 month

  9. 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)

    Measured: baseline ~ 3 month

  10. 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)

    Measured: 3 ~ 6 month

  11. 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)

    Measured: baseline ~ 3 month

  12. 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)

    Measured: 3 ~ 6 month

  13. Changes in Microbiome between baseline and 3rd month

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

    Measured: baseline ~ 3 month

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

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

    Measured: 3 ~ 6 month

  15. 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.

    Measured: baseline ~ 3 month

  16. 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.

    Measured: 3 ~ 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start10 May 2019
  3. Primary completion8 Feb 2022
  4. Study completion8 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927675
Sponsor's protocol ID
PA-1812-129-997
Status last verified
Jun 2023
First submitted
13 Jun 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38287431

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Healthy, run by Seoul National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic blood pressure (SBP) between baseline and 3rd month (time frame: baseline ~ 3 month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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