UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051961 |
|---|---|
| Receipt number | R000059304 |
| Scientific Title | Impact of daily physical activity levels on short-chain fatty acid concentrations and gut microbiota composition |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/08/24 10:04:59 |
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Basic information
Public title
Impact of daily physical activity levels on short-chain fatty acid concentrations and gut microbiota composition
Acronym
Impact of daily physical activity levels on short-chain fatty acid concentrations and gut microbiota composition
Scientific Title
Impact of daily physical activity levels on short-chain fatty acid concentrations and gut microbiota composition
Scientific Title:Acronym
Impact of daily physical activity levels on short-chain fatty acid concentrations and gut microbiota composition
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationships between daily levels of physical activity, concentrations of short-chain fatty acids (SCFAs), and the abundance of SCFA-producing bacteria in healthy young adults, and to ascertain the significance of routine physical activity from the perspective of gut microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentrations of short-chain fatty acids
Gut microbiota of composition
Key secondary outcomes
Body composition, Quadriceps muscle strength, Cardiorespiratory fitness, Daily physical activity levels (the number of steps, total waking time, walking energy expenditure, brisk walking time), Nutrient intake
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healty sedentary young adults
Key exclusion criteria
subjects with arrhythmia, history of ischemic heart disease, chronic heart failure, hypertension (with systolic BP more than 160 mmHg or diastolic BP more than 100 mmHg), and chronic disease such as diabetes, renal dysfunction or neuropsychiatric disorder.
The subjects judged to be inappropriate for enrolled to exercise program.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Emiko |
| Middle name | |
| Last name | Morita |
Organization
Aino University
Division name
Physical Therapy
Zip code
567-0012
Address
4-5-4 Higashioda Ibaraki city, Osaka
TEL
072-627-1711
e-morita@pt-u.aino.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Morita |
Organization
Aino University
Division name
Physical Therapy
Zip code
567-0012
Address
4-5-4 Higashioda Ibaraki city, Osaka
TEL
072-627-1711
Homepage URL
e-morita@pt-u.aino.ac.jp
Sponsor or person
Institute
Faculty of Health Science, Department of Physical Therapy, Aino University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aino University
Address
4-5-4 Higashioda Ibaraki city, Osaka
Tel
072-627-1711
e-morita@pt-u.aino.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.6084/m9.figshare.24201780.v1
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.6084/m9.figshare.24201780.v1
Number of participants that the trial has enrolled
30
Results
No significant differences were observed in short-chain fatty acids concentration between the active group and the less active group. Eubacterium were found to be independent contributors to butyric acid concentrations. Daily brisk walking at an intensity of 5METs or more did not directly affect the SCFA concentration but could be associated with the relative abundance of intestinal Eubacterium, the butyrate-producing bacteria.
Results date posted
| 2024 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study targeted 30 young adults in their twenties who were healthy and had no exercise habits.
Participant flow
All participants were classified into two groups based on the results of a daily physical activity measurement. Participants who engaged in brisk walking for at least 20 minutes per day at a speed equivalent to 4 METs or more and walked at least 7000 steps were categorized as the brisk walking group, while those who did not meet these criteria were classified as the non-brisk walking group.
Adverse events
None
Outcome measures
We assessed short-chain fatty acids concentration and the composition of the intestinal microbiota in fecal samples. We also assessed the daily physical activity using an accelerometer, and cardiorespiratory fitness by the incremental shuttle walking test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is cross-sectionalstudy. All the participants were measured body composition and motor ability as well as an assessment of daily physical activity levels, nutrient intake. In addition, fecal samples were collected. The participants were classified into two groups according to daily step counts and brisk walking time.
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059304
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/08/24 | 研究実施計画書1.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/08/24 | 一日の身体活動量が腸内短鎖脂肪酸量および腸内細菌に与える影響.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/08/24 | 一日の身体活動量が腸内短鎖脂肪酸量および腸内細菌に与える影響.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/59304
