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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035083
Receipt No. R000039996
Scientific Title An investigation study of antioxidant effect and improving blood circulation: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2019/11/30
Last modified on 2019/09/12

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Basic information
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
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Kadoya Sesame Mills Incorporated
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039996

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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