UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049014
Receipt number R000055811
Scientific Title An exploratory study to verify the effect on SIRT6 by practicing a hot yoga program at Woodstone Studios
Date of disclosure of the study information 2022/09/28
Last modified on 2022/12/21 17:07:30

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Basic information

Public title

An exploratory study to verify the effect on SIRT6 by practicing a hot yoga program at Woodstone Studios

Acronym

An exploratory study to verify the effect on SIRT6 by practicing a hot yoga program at Woodstone Studios

Scientific Title

An exploratory study to verify the effect on SIRT6 by practicing a hot yoga program at Woodstone Studios

Scientific Title:Acronym

An exploratory study to verify the effect on SIRT6 by practicing a hot yoga program at Woodstone Studios

Region

Japan


Condition

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to obtain evidence of "Woodstone Studio (WSS)" independently developed by Japan's largest hot yoga studio "LAVA".

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SIRT6
NK cell activity

Key secondary outcomes



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

60 years-old >

Gender

Female

Key inclusion criteria

[1]A female instructor belonging to LAVA who has worked at a WSS store for more than 6 months or at a regular floor store for more than 6 months
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who can come to the designated venue for this study and be inspected.
[4]Individuals judged appropriate for this study by responsible doctor

Key exclusion criteria

Individuals (who)
[1] contract disease and are under treatment
[2] under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[3] have a history of and/or contract serious diseases (eg, Uterine disease,liver disease, kidney disease, heart disease, lung disease, blood disease)
[4] receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[5] are or are possibly pregnant, or are breastfeeding
[6] are participating and/or had participated in other clinical studies within the last 3 months
[7] are judged as not appropriate to this study by a responsible doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yoshikazu
Middle name
Last name Yonei

Organization

Faculty of Life and Medical Sciences,Doshisha University

Division name

Anti-Aging Medical Research Center

Zip code

610-0392

Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name Seigo
Middle name
Last name Isozaki

Organization

Anti-Aging Bank Co.,Ltd.

Division name

Clinical trial support team

Zip code

101-0054

Address

3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo

TEL

03-5577-1010

Homepage URL


Email

isozaki@antiaging-bank.com


Sponsor or person

Institute

LAVA International,Inc.

Institute

Department

Personal name



Funding Source

Organization

LAVA International,Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Society of Glycative Stress Research

Address

5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo

Tel

03-6709-8842

Email

rinri-glycativestress@antiaging-bank.com


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

うえのあさがおクリニック


Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 28 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

Completed

Date of protocol fixation

2022 Year 09 Month 15 Day

Date of IRB

2022 Year 09 Month 21 Day

Anticipated trial start date

2022 Year 09 Month 22 Day

Last follow-up date

2022 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A total of 40 instructors, 20 who have worked at WSS stores for 6 months or longer and 20 who have worked at regular floor stores for 6 months or longer, among the instructors belonging to LAVA, will be subjected to a comparative study.


Management information

Registered date

2022 Year 09 Month 26 Day

Last modified on

2022 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055811


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name