UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038468
Receipt number R000043822
Scientific Title A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults
Date of disclosure of the study information 2019/11/02
Last modified on 2020/11/02 08:42:04

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Basic information

Public title

A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults

Acronym

A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults

Scientific Title

A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults

Scientific Title:Acronym

A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep for 4 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Brief Job Stress Questionnaire(BJSQ), OSA sleep inventory MA version

Key secondary outcomes

Profile of Mood States 2nd Edition-Adult Short


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of the test product for 4 weeks

Interventions/Control_2

Ingestion of the placebo for 4 weeks

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Male and female from 20 to 65 years old.
2) Subjects who feel stress when commuting or working in daily life
3) Subjects who are judged to be highly stressed by BJSQ
4) Subjects with "Slightly High / Frequent" of "Irritation" and "Slightly High / Frequent" of "Anxiety" in BJSQ

Key exclusion criteria

1)Subjects who routinely use food or medicine containing of DHMBA or oyster meat extract
2)Subjects who perform an act for the improvement of the fatigue, stress and the quality of the sleep at least once a week
3)Subjects who are under treatment or a history of mental illness, sleep apnea syndrome, chronic fatigue syndrome, or are strongly suspected
4)Subjects whose score for each scale of BJSQ is "High/Frequent" ("Vigor" is "Low/Infrequent")
5)Subjects who wake after sleep onset more than twice a week for nocturia, children crying at night or other reason
6)Night and day shift worker or manual laborer
7)Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care
8)Subjects who are a history of xerostomia
9)Subjects who has oral or dental problems with bleeding or develops the trouble at least once a week
10)Subjects who are have treated diseases related bowel movements and using drugs, or are regularly using commercially available constipation medicine
11)Subjects who cannot carry out the procedures of various tests to be carried out during this study
12)Subjects who are under treatment or have a history of serious diseases
13)Subjects who has a disease which may influence the outcome of the study
14)Subjects having possibilities for emerging allergy related to the study
15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination
16)Subjects who are planned to become pregnant
or are pregnant or lactating
17)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires
19)Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Mitsuhisa
Middle name
Last name Takahashi

Organization

Watanabe Oyster Laboratory, Co., Ltd.

Division name

Planning Department

Zip code

192-0154

Address

490-3, Shimoongata-Cho, Hachioji-City, Tokyo

TEL

042-651-8118

Email

gakujutsu@oyster.co.jp


Public contact

Name of contact person

1st name Hiroyasu
Middle name
Last name Shimada

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

h.shimada@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Watanabe Oyster Laboratory, Co., Ltd.

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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.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

2019 Year 11 Month 02 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

58

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

2019 Year 10 Month 10 Day

Date of IRB

2019 Year 10 Month 10 Day

Anticipated trial start date

2019 Year 11 Month 03 Day

Last follow-up date

2020 Year 02 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 01 Day

Last modified on

2020 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name