UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020779 |
|---|---|
| Receipt number | R000023981 |
| Scientific Title | A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity. |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/08/09 10:11:14 |
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Basic information
Public title
A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Acronym
A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Scientific Title
A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Scientific Title:Acronym
A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Region
| Japan |
Condition
Condition
Open distal gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study whether preoperative administration of amino acids, cystine and theanine, accelerate recovery from postoperative reduction of activity amount.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in amount of activity from 2 days before to 1 week after surgery measured using wristwatch-type motion logger.
Key secondary outcomes
Hematological and blood biochemistry indices before and 1, 3, 7, 14days after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of supplement containing 700mg of cystine and 280mg of theanine once daily for 10 days from 2days before until 7days after surgery.
Interventions/Control_2
No ingestion of supplement instead of the cystine and theanine.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Received a written informed consent by patient's self-determination.
2.Scheduled to receive open distal gastrectomy.
3.From 20 to less than 80 years old.
4.No severe complication before surgery.
Key exclusion criteria
1.Phenyl ketonuria.
2.Active infection.
3.Poorly controlled hypertension.
4.Poorly controlled diabetes.
5.Clinically important cardiac disease.
6.Severe pulmonary disease(e.g. interstitial pneumonia, fibrosis, severe emphysema).
7.History of clinically important psychopathic disorder or central nervous system damage.
8.Continuous systemic administration(iv or po) of steroid.
9.Pregnancy, breast-feeding, possible pregnancy, and willing to be pregnant.
10.Particpation for other studies.
11.Impossible of oral ingestion.
12.Judged ineligible by the principal investigator of sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchiya |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Director, GI Surgery
Zip code
Address
5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL
022-252-1111
tsuchiya@openhp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchiya |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Director, GI Surgery
Zip code
Address
5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL
022-252-1111
Homepage URL
tsuchiya@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center Sendai Open Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023981
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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