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 2022/04/03 10:08:00

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


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

2022 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051621


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name