UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022115
Receipt No. R000025495
Scientific Title A study of the influence of amino acid composition intake on vascular function in healthy adults.
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study of the influence of amino acid composition intake on vascular function in healthy adults.
Acronym A study of the influence of amino acid composition intake on vascular function in healthy adults.
Scientific Title A study of the influence of amino acid composition intake on vascular function in healthy adults.
Scientific Title:Acronym 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
1st name
Middle name
Last name Keiichi Nakagawa
Organization Tokyo Seaside Clinic
Division name director
Zip code
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
1st name
Middle name
Last name Saki Fukuchi
Organization TTC CO., LTD.
Division name Clinical Research Planning Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.