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
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
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
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
