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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032730
Receipt No. R000037327
Scientific Title A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Date of disclosure of the study information 2018/05/26
Last modified on 2018/11/09

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Basic information
Public title A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Acronym A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Scientific Title A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Scientific Title:Acronym A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of the ingestion of a single intake and 4 consecutive weeks of active test food on the blood flow, fatigue
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood flow
Key secondary outcomes Skin surface temperature, POMS2, skin questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 a single intake and 4 consecutive weeks of active test food
Interventions/Control_2 Ingestion of a single intake and 4 consecutive weeks of placebo food
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
30 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria (1) Female workers from 30 to 49 years old
(2) Clerical workers
(3) Subjects who are feeling fatigue because of work
Key exclusion criteria (1) Subjects who routinely use food or medicine containing of functional substance
(2) Subjects who performs an act for the improvement of the blood flow, the fatigue, stress, and the quality of the sleep
(3) Subjects who use the warm cream
(4) Night and day shift worker or manual laborer
(5) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
(6) Subjects who has under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome
(7) Subjects who has had a diagnosis of chronic fatigue syndrome
(8) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
(9) Smokers
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnair
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(13) 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
(14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Saito
Organization Medical Station Clinic
Division name None
Zip code
Address 3-12-8 Takabann, Meguro-ku, Tokyo, Japan
TEL 03-6452-2712
Email info@med-station.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakagawa
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Unitec Foods 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
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 05 Month 26 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 05 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 26 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037327

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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