UMIN-CTR Clinical Trial

Public title

Effect of use of mats with "A Distinctive 4-Layer 3-Dimensional Structure" on sleep quality,attention,quality of life,intestinal flora and blood special test for mild obese subjects.

Acronym

Effect of use of mats with "A Distinctive 4-Layer 3-Dimensional Structure" on sleep quality,attention,quality of life,intestinal flora and blood special test for mild obese subjects.

Scientific Title

Effect of use of mats with "A Distinctive 4-Layer 3-Dimensional Structure" on sleep quality,attention,quality of life,intestinal flora and blood special test for mild obese subjects.

Scientific Title:Acronym

Effect of use of mats with "A Distinctive 4-Layer 3-Dimensional Structure" on sleep quality,attention,quality of life,intestinal flora and blood special test for mild obese subjects.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study was to use "A Distinctive 4-Layer 3-Dimensional Structure" mattress for 8 weeks in mildly obese men and women between the ages of 50 and 65 for sleep quality, attention, quality of life, intestinal flora, and blood.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gut flora test (T-RFLP flora analysis)(0W,8W), Body composition test(0W,4W,8W)

Key secondary outcomes

OSA sleep inventory MA version,Japanese version of the Pittsburgh Sleep Quality Index,Anti-Aging QOL Common Questionnaire(AAQol)(0W,4W,8W),Cognitrax(0W,8W),IGF-1,DHEA-s,cortisol(0W,4W,8W),ABeta-40,ABeta-42,ApoA1,C3(0W,8W)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Use 4-layer special three-dimensional mattress(8Weeks)

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

Age-lower limit

50

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese male and females aged 50-65 years
[2]BMI is 25.0kg/m2 or more and less than 30.0kg/m2
[3]Individuals who are aware of mild sleep disorders such as waking up in the middle of the night (midway awakening), waking up early in the morning (early morning awakening), and not feeling well asleep (deep sleep disorder)
[4]Individuals who work 3 to 5 days a week during the day and are on weekends and public holidays
[5]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours
[6]Individuals who are sleeping alone
[7]Individuals who do not have a habit of drinking alcohol
[8]Individuals whose written informed consent has been obtained
[9]Individuals who can come to the designated examination date and receive the examination
[10]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who are currently ingesting or applying drugs
[3]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[5]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome
[6]Individuals who have or are suspected with the night urination, Prostate hypertrophy, or overactive bladder
[7]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[8]Individuals with a history of comorbidities and serious gastrointestinal disorders
[9]Individuals with severe constipation and diarrhea on a daily basis
[10]Individuals who cannot stop drinking during the test period
[11]smoker
[12]Individuals who have a habit of continuing to take functional foods, foods for specified health use, health foods, supplements in the past month, and those who plan to take them during the test period
[13]Individuals who donated 200 mL of blood in the past month or more than 400 mL within 3 months
[14]Individuals who may change their lifestyle during the test period, or who may have difficulty using the test mat due to travel, etc.
[15]Individuals who are currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials
[16]Individuals who are pregnant, breastfeeding or may become pregnant
[17]Individuals who are judged by the investigator to be inappropriate for this study

Target sample size

12

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

6100394

Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp

Name of contact person

1st name	Toshiyasu
Middle name
Last name	Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code

1100015

Address

6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo

TEL

03-6801-8400

Homepage URL

Email

info@tes-h.co.jp

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name

Organization

Nishikawa Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

うえのあさがおクリニック

Date of disclosure of the study information

2020

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

12

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

09

Month

15

Day

Date of IRB

2020

Year

09

Month

28

Day

Anticipated trial start date

2020

Year

10

Month

01

Day

Last follow-up date

2021

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

09

Month

24

Day

Last modified on

2021

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047804