UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022115 |
|---|---|
| Receipt number | 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 16:34:49 |
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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
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
s.fukuchi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025495
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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