UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of antioxidants supplementation on the quality of life
Title of the study (Brief title)	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	Naoki Miura
Organization	Medical Corporation Kanonkai Miura Clinic
Division name	Internal Medicine
Address	1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	tterashima@miula.co.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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