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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033863
Receipt No. 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

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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
Email 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
Email hayashi.masahiro@jxtg.com

Sponsor
Institute JXTG Nippon Oil & energy Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038619

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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