UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects. A Randomized, Double-blind, Placebo controlled Study.
Title of the study (Brief title)	A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test supplement on oxidative stress in healthy subjects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the effects on Measurement items related to oxidative stress
Key secondary outcomes	Evaluate the effects on mental and physical conditions by questionnaires and related-measurement items

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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 12 weeks
Interventions/Control_2	Ingestion of placebo food for 12 weeks
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Subjects with rather high level of HbA1c. (2) Subjects who were judged to have a high level of oxidative stress from the results of screening tests. (3) Subjects who understand objectives and protocol of this study with written consent.
Key exclusion criteria	(1) Subjects who have serious diseases requiring an urgent treatment, or who have chronic illness and use medicines constantly. (2) Subjects who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendectomy.) (3) Subjects who use supplements and health foods (including food for specified health use and food with nutrient function claims) constantly that could affect antioxidant status (4) Subjects who ingest many polyphenol-containing beverages such as green tea and coffee (more than 3 cups per day). (5) Subjects who declared that they have allergies to the ingredients of the test supplement. (6) Subjects who have a history of developing seasonal allergy during this study period (July - December). (7) Subjects who are pregnant or willing to be pregnant or breast-feeding during this study. (8) Subjects who have a current or history of drug dependence and/or alcoholism. (9) Subjects who were judged as unsuitable for this study by the principal investigator from the clinical examination performed in the screening test. (10) Subjects who are participating in other clinical trial that intake/apply any of food, drug, and cosmetics, or willing to participate. (11) Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size	112

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Asahi Group Holdings, 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 08 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 08 Month 19 Day
Last follow-up date	2017 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 04 Month 06 Day

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

Management information
Registered date	2017 Year 08 Month 03 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032635