UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the influence of amino acid composition intake on vascular function in healthy adults.
Title of the study (Brief title)	A study of the influence of amino acid composition intake on vascular function in healthy adults.
Region	Japan South America

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A study of the influence that the amino acid composition intake in the normal adult gives to a vascular function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	baPWV(brachial-ankle pulse wave velocity)(0,12 weeks)
Key secondary outcomes	1. FMD(flow-mediated dilatation) 2. ABI(ankle brachial index) 3. blood NOx(Nitrate+Nitrite) 4. blood amino acid concentration 5. ADMA(AsymmetricDimethylarginine) 6. SDPTG(second derivative of photoplethysmogram) 7. vascular age 8. VAS questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	2 test foods per day for 12 weeks
Interventions/Control_2	2 placebo foods per day 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

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males aged 45 to less than 69 years old or Females aged 55 to less than 69 years old. (2) Choosing subjects who judged it when the investigators are qualified among BMI of advance examination, girth of the abdomen, blood pressure, laboratory evidence and aim for the examination before intake. (3) Subjects whose screening value of baPWV is more than 1,400 cm/sec in right or left arm.
Key exclusion criteria	(1) Subjects who intake supplement and/or health foods, nutrition supplement, medicine, quasi-drug containing amino acid at advance examination. (2) Subjects who constantly eat watermelon at advance examination (e.g., more three times per week) (3) Subjects who constantly intake health foods and/or supplement or medicine, quasi-drug which may have vascular function improvement effect at advance examination (e.g., CoQ10, Nattokinase, Lutein, blueberry, Cassis, Vitamin E, Ginkgo leaf extract, melilot, Hesperidin as the polyphenols, Flavangenol, Pycnogenol) (4) Subjects having possibilities for emerging allergy related to the study. (5) Subjects who smoke at advance examination (including subjects who started smoking cessation within pre-three months at the time of advance examination) or hope smoking during study duration. (6) Subjects who ABI less than 0.90 at advance examination. (7) Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease, cerebrovascular disease, malignant, anomaly of aminoacid metabolism, arrhythmia) (8) Subjects having a disease requiring treatment. (9) Subjects with a disease under treatment. (10) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination. (11) Subjects who have a lifestyle affect the result of this study (ex. work on midnight shift) or subjects who are going to change to a lifestyle affect the result of this study (ex. work on midnight shift) (12) Subjects with a disease under treatment. (13) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire. (14) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study. (15) Subjects judged as unsuitable for the current study by the investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Keiichi Nakagawa
Organization	Tokyo Seaside Clinic
Division name	director
Address	GRAND PACIFIC LE DAIBA 3F 2-6-1, Daiba, Minato-ku, Tokyo
TEL	03-5579-0355
Email	k-nakagawa@ts-clinic.jp

Public contact
Name of contact person	Saki Fukuchi
Organization	TTC CO., LTD.
Division name	Clinical Research Planning Department
Address	1-20-2 Ebisunishi, Shibuya-ku, Tokyo JAPAN
TEL	03-5459-5329
Homepage URL
Email	s.fukuchi@ttc-tokyo.co.jp

Sponsor
Institute	TTC CO., LTD.
Institute
Department

Funding Source
Organization	KYOWA HAKKO BIO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	墨田病院（東京都）、東京シーサイドクリニック（東京都） Sumida clinic(Tokyo)、Tokyo seaside clinic(Tokyo)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 07 Day
Anticipated trial start date	2016 Year 05 Month 20 Day
Last follow-up date	2016 Year 10 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 28 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025495