UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043822