|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000026287 |
|
Date of registration:
|
24/02/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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
|
|
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 - Effects of green tea and black tea extracts-containing dietary supplement intake on motor function |
|
Date of first enrolment:
|
2017/02/27 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030194 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Makoto Terashima |
|
Address:
|
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Japan |
|
Telephone:
|
06-4801-8917 |
|
Email:
|
mterashima@oneness-sup.co.jp |
|
Affiliation:
|
Oneness support Co., Ltd. Clinical trial Division |
|
|
Name:
|
Koji Wakame |
|
Address:
|
Maeda,Teine-ku,Sapporo,Hokkaido,006-8590
Japan |
|
Telephone:
|
011-676-8682 |
|
Email:
|
wakame-k@hokuytakudai.ac.jp |
|
Affiliation:
|
Hokkaido Pharmaceutical University School of Pharmacy Pharmacology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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
Age minimum:
30years-old
Age maximum:
59years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy Adult
|
|
Intervention(s)
|
12-week continuous intake of green tea and black tea extracts-containing dietary supplement(low dose)
12-week continuous intake of green tea and black tea extracts-containing dietary supplement (high dose)
12-week continuous intake of placebo
|
|
Primary Outcome(s)
|
|
VAS (fatigue item, degree of fatigue recovery after exercise, etc.)
|
|
Secondary Outcome(s)
|
|
Lactic acid,red blood cell count,MCV,CK, Inflammatory cytokines (IL-1beta, IL-6), Salivary cortisol
|
|
Source(s) of Monetary Support
|
|
WAKASA SEIKATSU Co., Ltd.
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|