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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038468
Receipt No. 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 2019/11/03

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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
Institute TTC Co., Ltd.
Institute
Department

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
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 Open public 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
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.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


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