UMIN-CTR Clinical Trial

Public title

A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability : A randomized, double-blind, placebo controlled trial

Acronym

A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability

Scientific Title

A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability : A randomized, double-blind, placebo controlled trial

Scientific Title:Acronym

A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability

Region

Japan

Condition

Adults with higher oxidative stress level and lower antioxidant ability

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of ingestion of food containing a plurality of components for 8 consecutive weeks on blood oxidative stress level, antioxidant ability, visual acuity and ocular tension in subjects with higher oxidative stress level and lower antioxidant ability

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

BAP
Evaluate at points of 4-week and 8-week

Key secondary outcomes

d-ROMs, 8-OHdG, BAP/d-ROMs, Oxidative stress level, Endothelin, NO, visual acuity, ocular tension

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

Food containing a plurality of components, twice a day for 8 weeks

Interventions/Control_2

Placebo without a plurality of components, twice a day for 8 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

40

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Men and women aged from 40 to 65
(2) higher oxidative stress level and lower antioxidant ability

Key exclusion criteria

(1)Subjects who regularly visit to ophthalmologic hospital for serious eye disease
(2)Subjects who answered that there was a history of strength myopia in questionnaire
(3)Subjects who received ophthalmic surgery within 3 months
(4)Subjects who have a disease affecting the study results (e.g., cancer, hypertension, diabetes, amblyopia, autoimmune disease, thyroid dysfunction)
(5) Subjects who have been taking foods affecting the study results once a week or more in the past month or expected to use once a week or more during study
(6) Subjects who may have allergy to the test foods
(7) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9) Subjects who have participated in other clinical study within the last one month prior to the current study
(10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(12) Subjects who are judged as unsuitable by doctor for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Masami Sato

Organization

WAKAMOTO PHARMACEUTICAL CO., LTD.

Division name

Health Care Business Development Dept.

Zip code

Address

2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo

TEL

03-3279-0387

Email

m.sato@wakamoto-pharm.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroyasu Shimada

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

WAKAMOTO PHARMACEUTICAL CO., 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

2016

Year

12

Month

23

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

2016

Year

12

Month

21

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

22

Day

Last modified on

2017

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029214