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

• Sponsor: Seoul National University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05927675
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Actual Duration (Months): 33
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Physical activity	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Dynamic Profiling of Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: Feb 8, 2022
• Actual Study Completion Date: Feb 8, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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

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

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

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

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

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

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

5. Changes in hemoglobin A1c (HbA1c) between baseline and 3rd month [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [3 ~ 6 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 59 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University

Investigators

• Principal Investigator: Ji-Yeob Choi, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JiYeob Choi, Professor, Seoul National University
• ClinicalTrials.gov Identifier: NCT05927675
• Other Study ID Numbers: PA-1812-129-997
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by JiYeob Choi, Professor, Seoul National University: Microbiome; Metabolite; Physical activity

Study Results

No Results Posted as of Jul 3, 2023