UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045186 |
|---|---|
| Receipt number | R000051621 |
| Scientific Title | Effects of lifestyle modifications on gut microbiome and metabolites: N-of-1 crossover intervention trial |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2025/03/26 23:06:36 |
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Basic information
Public title
Effects of lifestyle modifications on gut microbiome and metabolites: N-of-1 crossover intervention trial
Acronym
Lifestyle and gut microbiome
Scientific Title
Effects of lifestyle modifications on gut microbiome and metabolites: N-of-1 crossover intervention trial
Scientific Title:Acronym
Lifestyle and gut microbiome
Region
| Japan |
Condition
Condition
n/a
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the effects of repeating lifestyle modifications on variations in gut microbiome and metabolites
Basic objectives2
Others
Basic objectives -Others
To observe the changes in microbiome over time by repeating multiple lifestyle modifications by one participant
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
gut microbiota composition
Key secondary outcomes
abundance ratio of each bacterial species, concentration of each metabolite, time-series fluctuations in physical activity, dietary intake, and sleep
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Increased protein intake (1wk x 6times / yr), vegetable intake (1wk x 6times / yr), and physical activity (1wk x 6times / yr)
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
| 50 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
An physically indipendent man with prevotella-entyerotype microbiota
Key exclusion criteria
Patients with serious illness, like cancers, cardiovascular diseases, diabetes, and gastrointestinal disorders
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
0429-47-7313
cardiovascular0327@mac.com
Public contact
Name of contact person
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
0429-47-7313
Homepage URL
cardiovascular0327@mac.com
Sponsor or person
Institute
Faculty of Sport Sciences, Waseda University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
Shinshin Corp.
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsuka-cho, Sinjuku, Tokyo, Japan
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学スポーツ科学学術院（埼玉県）、医薬基盤・健康・栄養研究所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051621
