UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032730 |
|---|---|
| Receipt number | 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 10:19:41 |
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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
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
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037327
