UMIN-CTR Clinical Trial
| 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 |
* 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
A randomized controlled trial for improving oxidative stress and antioxidative potential in human
Acronym
A trial for improving oxidative stress and antioxidative potential
Scientific Title
A randomized controlled trial for improving oxidative stress and antioxidative potential in human
Scientific Title:Acronym
A trial for improving oxidative stress and antioxidative potential
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effect of "FFC (r) Pairogen" on oxidative stress and antioxidative potential in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
microarray analys8s of miRNA (performed to the part of participants)
Questionnaires (Likert scale)
Blood test
Urianalysis
Physical examinations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test material: FFC Pairogen 180 ml
Tree times/day (540 ml/day)
Interventions/Control_2
Duration: 8 weeks
Test material: bottled water 500 ml
One bottle per day (500 ml/day)
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Healthy adults, who feel fatigue daily
b) Persons who are between 40 and 60 years old
Key exclusion criteria
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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO, Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO, Inc.
Division name
R&D department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO, Inc.
Institute
Department
Personal name
Funding Source
Organization
AKATSUKA Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
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
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)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352939315000044
Number of participants that the trial has enrolled
22
Results
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.
Results date posted
| 2021 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 20 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
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 |
