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

June 22, 2023 updated by: JiYeob Choi, Seoul National University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise intervention
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Systolic blood pressure (SBP) between baseline and 3rd month
Time Frame: baseline ~ 3 month
blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)
baseline ~ 3 month
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 ~ 6 month
Changes in diastolic blood pressure (DBP) between baseline and 3rd month
Time Frame: baseline ~ 3 month
blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)
baseline ~ 3 month
Changes in diastolic blood pressure (DBP) between 3rd month and 6th month
Time Frame: 3 ~ 6 month
blood pressure (mmHg) (Omron Corporation, Kyoto, Japan)
3 ~ 6 month
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)
baseline ~ 3 month
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)
3 ~ 6 month
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)
baseline ~ 3 month
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)
3 ~ 6 month
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)
baseline ~ 3 month
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)
3 ~ 6 month
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)
baseline ~ 3 month
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)
3 ~ 6 month
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.
baseline ~ 3 month
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.
3 ~ 6 month
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.
baseline ~ 3 month
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.
3 ~ 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ji-Yeob Choi, Seoul National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PA-1812-129-997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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