UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026287 |
|---|---|
| Receipt number | R000030194 |
| Scientific Title | Effects of green tea and black tea extracts-containing dietary supplement intake on motor function : a randomized double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2018/07/13 15:59:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
: a randomized double-blind, parallel-group, placebo-controlled study
Acronym
Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
Scientific Title
Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
: a randomized double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the influence of dietary supplement intake on motor function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (fatigue item, degree of fatigue recovery after exercise, etc.)
Key secondary outcomes
Lactic acid,red blood cell count,MCV,CK,
Inflammatory cytokines (IL-1beta, IL-6),
Salivary cortisol
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week continuous intake of green tea and black tea extracts-containing dietary supplement(low dose)
Interventions/Control_2
12-week continuous intake of green tea and black tea extracts-containing dietary supplement (high dose)
Interventions/Control_3
12-week continuous intake of placebo
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)30<=Age=<59 of healthy men and women
Key exclusion criteria
(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who are likely to have allergic symptoms due to components contained in the test food
(3) Subjects who indicate disorder of heart and lung function
(4) Subjects who indicate abnormal parameter in liver or kidney function
(5) Subjects who had a gastrointestinal surgery
(6) Subjects with a disease under treatment now
(7) Subjects with drug or food allergy
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods
(10) Subject who consume exscessive alcohol
(11) Smoker.
(12) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(13) Subjects who is participating in the other study or plannning to participate during the study period
(14) Subjects who isdeemed unsuitable by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Wakame |
Organization
Hokkaido Pharmaceutical University School of Pharmacy
Division name
Pharmacology
Zip code
Address
Maeda,Teine-ku,Sapporo,Hokkaido,006-8590
TEL
011-676-8682
wakame-k@hokuytakudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
WAKASA SEIKATSU Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Fitness and Sports in Kanoya
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
| 2017 | Year | 02 | 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
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | 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
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030194
