UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020995 |
|---|---|
| Receipt number | R000024237 |
| Scientific Title | Effects of antioxidants supplementation on the quality of life |
| Date of disclosure of the study information | 2017/12/19 |
| Last modified on | 2018/07/13 15:56:39 |
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Basic information
Public title
Effects of antioxidants supplementation on the quality of life
Acronym
Effects of antioxidants supplementation on the quality of life
Scientific Title
Effects of antioxidants supplementation on the quality of life
Scientific Title:Acronym
Effects of antioxidants supplementation on the quality of life
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects about 8 weeks antioxidants supplementation on the quality of life by a randomized, double-blind, placebo-controlled study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 'Vitality' scores in the questionnaire of health related QOL.
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Period:8 weeks
Supplementation:Antioxidants
Interventions/Control_2
Period:8 weeks
Supplementation:Placebo
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese subjects aged from 40 to 69 years old
2.Subjects who are office workers.
3.Subjects who feel tired or low in vitality.
4.Subjects who have the 'Vitality' scores lower than 62.8(the national standard value) in SF-36 v2 (the questionnaire of the health related QOL) .
Key exclusion criteria
1.Subjects who have the history of diabetes, liver disease, kidney disease, heart disease, respiratory disease, chronic fatigue syndrome, or other severe diseases
2.Subjects who have had the surgery of the digestive tract.
3.Subjects who have the disease under treatment.
4.Subjects who have food or chemical allergies.
5.Smoker.
6.Subjects who regularly use health food, supplements, medicines (for example, statins, anti-hypertensive agents, hypoglycemic agents, or warfarine) or have used them within 1 month.
7.Subjects who drink excessive alcohol, or who can not stop drinking alcohol for the test day and the day before the test day.
8.Subjects who have been suffering from anemia.
9.Subjects who plays heavyexercise or who are on a diet restriction.
10.Subjects who is pregnant or breastfeeding
11.Subjects who take part in another clinical study during the study.
12.Subjects whose BMI are less than 18.5 or over 25.0.
13.Subjects whose clinical test value, blood pressure, pulse rate are markedly over or below the standard value.
14.Subjects deemed unsuitable by the investigator for other reasons
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Miura |
Organization
Medical Corporation Kanonkai Miura Clinic
Division name
Internal Medicine
Zip code
Address
1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
tterashima@miula.co.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
1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
shiken@oneness-sup.co.jp
Sponsor or person
Institute
Oneness support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KYOWA HAKKO BIO CO., LTD
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
| 2017 | Year | 12 | Month | 19 | 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
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | 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
| 2016 | Year | 02 | Month | 12 | 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=R000024237
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
