![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016817 |
Receipt No. | R000019524 |
Scientific Title | Anti-fatigue effect by one week continuous intake of deep-sea-water containing water in the adult males: a randomized cross-over study. |
Date of disclosure of the study information | 2015/03/17 |
Last modified on | 2015/07/01 |
Basic information | ||
Public title | Anti-fatigue effect by one week continuous intake of deep-sea-water containing water in the adult males: a randomized cross-over study. | |
Acronym | Anti-fatigue effect by deep-sea-water containing water. | |
Scientific Title | Anti-fatigue effect by one week continuous intake of deep-sea-water containing water in the adult males: a randomized cross-over study. | |
Scientific Title:Acronym | Anti-fatigue effect by deep-sea-water containing water. | |
Region |
|
Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to clarify the anti-fatigue effect of intake of deep-sea-water containing water in healthy males. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | evaluation of anti-fatigue index (lactic acid, myoglobin, noradrenaline and cortisol in serum). lassitude levels by a visual analog scale (VAS). |
Key secondary outcomes | immunological test(serum IL-6).
body measurement. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
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 |
|
|
Interventions/Control_1 | A-Washout-B | |
Interventions/Control_2 | B-Washout-A | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male | |||
Key inclusion criteria | Key inclusion criteria are as follows.
1) Who can understand its contents, and who can consent to the study participation by receiving the explanation. 2) Healthy men who is less than 35 years old more than 20 years old does not be receiving medical treatment of disease (especially circulator disease) at the time of informed consent. |
|||
Key exclusion criteria | Key exclusion criteria are as follows.
1) Who has habit of intake test water or control water. And who has intake mineral water containing more than 0.3mg/100mL of Mg because the average Mg concentration is 0.25mg/100mL in soft water. 2) Who has using drug, food and instrument that are judged unsuitable for this study by principle investigator and subinvestigator. 3) Who is participates in other interventional study or who is planning to participate. 4) Who has donated over 400mL of blood within the last three months of the date of consent or over 200mL of blood within the last one month of the date of consent. 5) Who is judged unsuitable for this study by principle investigator and subinvestigator. |
|||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Miyake Medical Institute Group | ||||||
Division name | medical office | ||||||
Zip code | |||||||
Address | 1-10-16, Ban-cho, Takamatsu-shi, Kagawa-Ken | ||||||
TEL | 087-831-2101 | ||||||
takeruna@miyake.or.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Linking Setouchi Innate immune Network | ||||||
Division name | Secretariat | ||||||
Zip code | |||||||
Address | 3rd floor, 2217-16, Hayashi-cho,Takamatsu-shi, Kagawa-Ken | ||||||
TEL | 087-867-9201 | ||||||
Homepage URL | |||||||
npolsinlsin@lsin.org |
Sponsor | |
Institute | Linking Setouchi Innate immune Network |
Institute | |
Department |
Funding Source | |
Organization | DyDo Takenaka Beverage Inc. |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019524 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |