UMIN-CTR Clinical Trial

Public title

A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
A Randomized, Double-blind, Placebo controlled Study.

Acronym

A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.

Scientific Title

A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
A Randomized, Double-blind, Placebo controlled Study.

Scientific Title:Acronym

A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp

Name of contact person

1st name
Middle name
Last name	Yoshika Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

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

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Asahi Group Holdings, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

07

Month

11

Day

Date of IRB

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

Other related information

Registered date

2017

Year

08

Month

03

Day

Last modified on

2019

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032635