UMIN-CTR Clinical Trial

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