Unique ID issued by UMIN | UMIN000012608 |
---|---|
Receipt number | R000014703 |
Scientific Title | A randomized controlled trial for improving oxidative stress and antioxidative potential in human |
Date of disclosure of the study information | 2013/12/17 |
Last modified on | 2021/05/24 10:01:37 |
A randomized controlled trial for improving oxidative stress and antioxidative potential in human
A trial for improving oxidative stress and antioxidative potential
A randomized controlled trial for improving oxidative stress and antioxidative potential in human
A trial for improving oxidative stress and antioxidative potential
Japan |
Healthy adults
Adult |
Others
YES
To investigate the effect of "FFC (r) Pairogen" on oxidative stress and antioxidative potential in human.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Oxidative stress and antioxidant potential
potential anti oxidant (PAO)
serum total antioxidant status (STAS)
diacron-reactive oxygen metabolites (d-ROMs)
bioantioxidant power (BAP)
8-hydroxy-2'-deoxyguanosine (8-OHdG)
propanoyl lysine (PRL)
hexanoyl lysine (HEL)
microarray analys8s of miRNA (performed to the part of participants)
Questionnaires (Likert scale)
Blood test
Urianalysis
Physical examinations
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
Duration: 8 weeks
Test material: FFC Pairogen 180 ml
Tree times/day (540 ml/day)
Duration: 8 weeks
Test material: bottled water 500 ml
One bottle per day (500 ml/day)
40 | years-old | <= |
60 | years-old | >= |
Male and Female
a) Healthy adults, who feel fatigue daily
b) Persons who are between 40 and 60 years old
a) Persons who have previous medical history of heart failure or myocardial infarction
b) Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease
c) Persons who take medicines, herbal medicines, or dietary supplements
d) Persons who are allergic to medicines, or foods related to the test material of this trial
e) Pregnant women, lactating women, or women who want to get pregnant during the trial period
f) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
g) Persons who are judged not suitable to participate in this trial by physician.
20
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
AKATSUKA Co., Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2013 | Year | 12 | Month | 17 | Day |
Unpublished
Published
https://www.sciencedirect.com/science/article/pii/S2352939315000044
22
Hiroe T, Akatsuka K, Yamashita S, Suzuki N, Yamamoto K, Doyo W, Takara T. Regulation of microRNA expression in humans following ingestion of the whole food FFC(R) Pairogen - A preliminary, pilot study. Clinical Nutrition Experimental. 2015; 2: 1-8.
2021 | Year | 05 | Month | 24 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2013 | Year | 05 | Month | 20 | Day |
2013 | Year | 05 | Month | 22 | Day |
2013 | Year | 09 | Month | 03 | Day |
2013 | Year | 09 | Month | 20 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 15 | Day |
2013 | Year | 12 | Month | 17 | Day |
2021 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014703
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |