UMIN-CTR Clinical Trial

Public title

An investigation study of antioxidant effect and improving blood circulation: A randomized double-blind placebo-controlled trial

Acronym

An investigation study of antioxidant effect and improving blood circulation

Scientific Title

An investigation study of antioxidant effect and improving blood circulation: A randomized double-blind placebo-controlled trial

Scientific Title:Acronym

An investigation study of antioxidant effect and improving blood circulation

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of the test food on antioxidant effect and improving blood circulation

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Blood flow velocity
2. Visibility of the blood vessels
3. The density of the blood vessels
4. The blood vessels diameter
5. The distance between the blood vessels
6. The length of the blood vessels
7. The shape of the blood vessels

*^1-7 Measure before consumption and at 4 weeks after consumption

Key secondary outcomes

1. Diacron-reactive oxygen metabolites (d-ROM)
2. Biological antioxidant potential (BAP)
3. Urinary 8-OHdG
4. Potential anti-oxidant (PAO) in blood
5. Simplified oxidative stress profile (OSP)
6. Subjective symptoms

*^1-6 Measure before consumption and at 4 weeks after consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test food: Pure white sesame oil
Administration: Eat 14 g of the sesame oil or eat the oil with bread per day during the breakfast
* Daily dose should be eaten within the day. If you forget to eat the oil, eat the oil as soon as you remember within the day.

Interventions/Control_2

Duration: 4 weeks
Test food: Pure white sesame oil with vitamin E
Administration: Eat 14 g of the sesame oil or eat the oil with bread per day during the breakfast
* Daily dose should be eaten within the day. If you forget to eat the oil, eat the oil as soon as you remember within the day.

Interventions/Control_3

Duration: 4 weeks
Test food: Canola oil
Administration: Eat 14 g of the sesame oil or eat the oil with bread per day during the breakfast
* Daily dose should be eaten within the day. If you forget to eat the oil, eat the oil as soon as you remember within the day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who are experiencing feeling cold

3. Subjects who are experiencing fatigue

4. Subjects who are judged as eligible to participate in the study by the physician

5. Subjects who are selected relatively slow in blood flow rate at screening (before consumption)

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily

5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements

6. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients. Particularly allergic to sesame.

7. Subjects who have severe anemia (treatment for anemia at a clinic)

8. Subjects who are using medications (except medicine for external use, moisturizing, or sunscreen)

9. Subjects who have the smoking habit

10. Subjects who are wearing nail polish or applying cuticle oil to their nail

11. Subjects who have hangnail from fingertips of middle, ring, and little fingers

12. Subjects who have suppuration or inflammation from fingertips of middle, ring, and little fingers

13. Subjects who are chipping off the cuticle on fingernails of middle, ring, and little fingers

14. Subjects who are pregnant, breast-feeding, or planning to become pregnant

15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

16. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Target sample size

30

Name of lead principal investigator

1st name	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Kadoya Sesame Mills Incorporated

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

info@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2019

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

33

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

2018

Year

11

Month

20

Day

Date of IRB

2018

Year

11

Month

20

Day

Anticipated trial start date

2018

Year

12

Month

01

Day

Last follow-up date

2019

Year

03

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

30

Day

Last modified on

2019

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039996