UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020995
Receipt No. 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

* 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 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
Email 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
Email shiken@oneness-sup.co.jp

Sponsor
Institute Oneness support Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.