UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033863 |
|---|---|
| Receipt number | R000038619 |
| Scientific Title | A study to evaluate the effect of intake of astaxanthin on the status of stress and sleep in adult. |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2019/08/26 09:07:32 |
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Basic information
Public title
A study to evaluate the effect of intake of astaxanthin on the status of stress and sleep in adult.
Acronym
A study to evaluate the effect of intake of astaxanthin on the status of stress and sleep.
Scientific Title
A study to evaluate the effect of intake of astaxanthin on the status of stress and sleep in adult.
Scientific Title:Acronym
A study to evaluate the effect of intake of astaxanthin on the status of stress and sleep.
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 astaxanthin on the status of stress and sleep for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of POMS2
Key secondary outcomes
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
The treatment group will receive oral administration of three jellies including 2 mg astaxanthin twice daily (12 mg astaxanthin/ 6 jellies /day).
Interventions/Control_2
The placebo group will receive oral administration of three astaxanthin-free jellies twice daily (6 jellies /day).
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age.
(2) Subjects who are targeted of high ranks in depression score of POMS2 in (1).
Key exclusion criteria
(1) Subjects who are 0mm as a result of VAS stress.
(2) Subjects who routinely use food or medicine containing of astaxanthin.
(3) Night and day shift worker or manual laborer.
(4) Subjects with the smoking custom.
(5) Bed time is after 2:00
(6) Subjects who drink much alcohol.
(7) Subjects who dose not engage in the periodical labor.
(8) Subjects who has got a rash with surgical tape, or may become infected with surgical tape, or that tape is easy to come off.
(9) Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor.
(10) Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome.
(11) Subjects diagnosed with chronic fatigue syndrome.
(12) Subjects who 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.
(13) Subjects who have oral or dental problems with bleeding.
(14) Subjects who were under treatment or have a history of serious diseases(e.g., diabetes, liver disease, kidney disease, or heart disease).
(15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires.
(16) Those who can not carry out the procedures of various tests to be carried out during this study.
(17) Subjects having possibilities for emerging allergy related to the study.
(18) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(19) 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.
(20) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
I omit (21) for input regulation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Uemura |
Organization
JXTG Nippon Oil & energy Corporation
Division name
Biotechniques Group Function materials Research and Development Section Function materials Company
Zip code
Address
8, Chidoricho, Naka-ku, Yokohama-shi, Kanagawa
TEL
045-625-7134
uemura.takeshi.922@jxtg.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Hayashi |
Organization
JXTG Nippon Oil & energy Corporation
Division name
Biotechniques Group Function materials Research and Development Section Function materials Company
Zip code
Address
8, Chidoricho, Naka-ku, Yokohama-shi, Kanagawa
TEL
045-625-7172
Homepage URL
hayashi.masahiro@jxtg.com
Sponsor or person
Institute
JXTG Nippon Oil & energy Corporation
Institute
Department
Personal name
Funding Source
Organization
JXTG Nippon Oil & energy Corporation
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
Address
Tel
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
| 2018 | Year | 08 | Month | 24 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038619
